[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-rdm-express-inc-729223-09112026":3,"fda-latest-sync-dates":29},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":27,"updated_at":28},21672,"rdm-express-inc-729223-09112026","Warning Letter","RDM Express Inc.",null,"Human Foods Program","CGMP\u002FFood\u002FPrepared, Packed or Held Under Insanitary Conditions\u002FAdulterated","2026-10-13","2026-09-11","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Frdm-express-inc-729223-09112026","729223","Food & Beverages","VIA Electronic Mail","Mr. Boris Dinerman","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">VIA Electronic Mail\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Food & Beverages                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Mr. Boris Dinerman\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">CEO\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>RDM Express Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">2000 McKinnon Ave Bldg 427, Unit #12\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">San Francisco\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">94124\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:(b)(6), (b)(7)(C)\"> (b)(6), (b)(7)(C)\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Human Foods Program\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>September 11, 2026\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp class=\"text-align-center\">Re: CMS #729223\u003C\u002Fp>\u003Cp>Dear Mr. Dinerman:\u003C\u002Fp>\u003Cp>The United States Food and Drug Administration (FDA) inspected your manufacturing facility, located at 2000 McKinnon Ave, Bldg 427, Unit #12, San Francisco, CA 94124, between February 18, 2026, and March 10, 2026. During our inspection of your facility, an FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Based on FDA's inspectional findings and analytical results for finished product samples of your Fermented Cabbage, we have determined that your ready-to-eat (RTE) Fermented Cabbage\u002FSour Cabbage products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and FDA's regulations through links on FDA's website at www.fda.gov.\u003C\u002Fp>\u003Cp>Further, a review of the Russian Style Kvas Drink, Sour Cabbage, and Half Sour Pickles product labels collected during the inspection revealed significant violations of the labeling regulations for foods under 21 CFR Part 101. These violations render your product to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], as discussed below.\u003C\u002Fp>\u003Cp>At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations. To date, FDA has not received your written response. After reviewing the inspectional findings, we are issuing this letter to advise you of FDA’s concerns.\u003C\u002Fp>\u003Cp>\u003Cstrong>\u003Cu>Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)\u003C\u002Fu>\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>1. You did not identify and evaluate known or reasonably foreseeable hazards to determine whether they required preventive controls, as required by 21 CFR 117.130(a)(1).\u003C\u002Fp>\u003Cp>Specifically, you manufacture a refrigerated, RTE Fermented Cabbage\u002FSour Cabbage product. However, the hazard analysis in your document titled “Food Safety Plan for Acidified & Fermented Foods” dated April 30, 2025, did not identify and evaluate the following hazards requiring a preventive control:\u003C\u002Fp>\u003Cp>a. Recontamination with environmental pathogens (e.g., Listeria monocytogenes)\u003C\u002Fp>\u003Cp>Employees \u003Cstrong>(b)(4)\u003C\u002Fstrong> package Fermented Cabbage\u002FSour Cabbage into \u003Cstrong>(b)(4)\u003C\u002Fstrong> pails and \u003Cstrong>(b)(4)\u003C\u002Fstrong> containers in the production room, under ambient conditions, exposing RTE product to the environment. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. A knowledgeable person manufacturing\u002Fprocessing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control (e.g., sanitation controls). Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR 117.135(c)(3)).\u003C\u002Fp>\u003Cp>You have a document titled “PROCEDURE FOR CLEANING AND SANITIZING OF EQUIPMENT” which, among other things, lists steps such as \u003Cstrong>(b)(4)\u003C\u002Fstrong>, washing, rinsing, \u003Cstrong>(b)(4)\u003C\u002Fstrong> drying. However, this document does not include procedures for monitoring, corrective actions, and verification.\u003C\u002Fp>\u003Cp>Furthermore, you provided copies of your “Sanitation Checklist”, “Sanitation Log”, and “Deep Cleaning Checklist”. However, none of these documents identify what equipment was cleaned and sanitized or who performed the cleaning.\u003C\u002Fp>\u003Cp>Furthermore, you provided a copy of your “Hygiene Checklist” which indicates that you monitor for glove use and handwashing \u003Cstrong>(b)(4)\u003C\u002Fstrong>. This frequency is insufficient to ensure that the hazard of pathogen contamination is controlled during production of fermented cabbage. Additionally, this “Hygiene Checklist” includes a “Compliant” column, which was marked “N” (no) by an employee with initials “\u003Cstrong>(b)(4)\u003C\u002Fstrong>” for \u003Cstrong>(b)(4)\u003C\u002Fstrong> dates recorded between October 27, 2025 and February 23, 2026. However, there is no documentation identifying the cause of non-compliance or any corrective actions taken in response.\u003C\u002Fp>\u003Cp>None of the above-mentioned records were reviewed for completeness and accuracy within seven working days of the records being created, as required under 21 CFR 117.165(a)(4).\u003C\u002Fp>\u003Cp>Lastly, you do not have an environmental monitoring program, nor do you conduct any environmental monitoring to verify that your sanitation procedures are effectively controlling the hazard of environmental pathogens, such as Listeria monocytogenes.\u003C\u002Fp>\u003Cp>b. Parasites (e.g., \u003Cem>Cyclospora\u003C\u002Fem>) and viruses (e.g., Norovirus and Hepatitis A) in \u003Cstrong>(b)(4)\u003C\u002Fstrong> cranberries\u003C\u002Fp>\u003Cp>You receive \u003Cstrong>(b)(4)\u003C\u002Fstrong> cranberries, which is an ingredient used in your refrigerated, RTE Fermented Cabbage\u002FSour Cabbage product. Cranberries, like other berries, have been associated with parasites such as \u003Cem>Cyclospora\u003C\u002Fem> and viruses such as Norovirus and Hepatitis A. Oocysts of \u003Cem>Cyclospora\u003C\u002Fem> can be shed by infected hosts during harvesting, and depending on time and temperature, \u003Cstrong>(b)(4)\u003C\u002Fstrong> may not be effective in appropriately destroying \u003Cem>Cyclospora\u003C\u002Fem>. Similarly, Norovirus and Hepatitis A are known to persist on berry surfaces and are not reliably inactivated by \u003Cstrong>(b)(4)\u003C\u002Fstrong>. Your fermentation process does not appear adequate to control the hazard of growth and\u002For survival of parasites, such as \u003Cem>Cyclospora\u003C\u002Fem>, and viruses, such as Norovirus and Hepatitis A, if they are already present in the \u003Cstrong>(b)(4)\u003C\u002Fstrong> cranberries at receiving. Additionally, your product’s formulation does not provide an adequate “kill step” for Norovirus, Hepatitis A, or \u003Cem>Cyclospora\u003C\u002Fem>. Finally, the \u003Cstrong>(b)(4)\u003C\u002Fstrong> cranberries are used in a RTE application and do not undergo a validated lethality step. A knowledgeable person manufacturing\u002Fprocessing food in your circumstances would identify the above-mentioned parasites and viruses as a hazard requiring a preventive control (e.g., a supply-chain control) in this ingredient. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control due to a hazard must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR 117.410).\u003C\u002Fp>\u003Cp>2. Your written process preventive control, monitoring, and verification procedures were not appropriate to significantly minimize or prevent hazards requiring preventive controls, as required by 21 CFR 117.135(c)(1).\u003C\u002Fp>\u003Cp>Specifically, your document titled “Food Safety Plan for Acidified & Fermented Foods” dated April 30, 2025, identifies a “preventive measure” of “Finished product pH below \u003Cstrong>(b)(4)\u003C\u002Fstrong>” to control the hazard of “Pathogens: Clostridium botulinum, Listeria monocytogenes” at your “pH Testing (\u003Cstrong>(b)(4)\u003C\u002Fstrong>)” step. However, we note that pH alone is insufficient to control all relevant pathogens of concern. While reducing pH before packaging may limit pathogen growth, your process preventive control must also account for pathogen survival. \u003Cem>Listeria monocytogenes\u003C\u002Fem> is an acid-tolerant pathogen that can survive the fermentation process if introduced through raw ingredients or environmental contamination, and may persist even at a pH of \u003Cstrong>(b)(4)\u003C\u002Fstrong>. Similarly, product formulation alone does not prevent or eliminate vegetative bacterial pathogens—such as \u003Cem>Listeria\u003C\u002Fem>, \u003Cem>E. coli\u003C\u002Fem>, and \u003Cem>Salmonella\u003C\u002Fem>—that may be associated with incoming raw ingredients.\u003C\u002Fp>\u003Cp>On February 25, 2026, FDA collected a sample of RTE fermented cabbage from your facility (sample # 1319005) and found and pH range of 4.0-4.17, a range at which \u003Cem>Listeria monocytogenes\u003C\u002Fem> is known to survive, and a water activity of 0.98. This water activity level represents an optimal moisture environment for bacteria to survive or thrive, further demonstrating that pH alone does not constitute an adequate preventive control when other intrinsic factors remain permissive for pathogen survival and growth.\u003C\u002Fp>\u003Cp>Furthermore, your written process preventive control document titled “Critical Control Point (CCP) Chart” references an SOP titled \"PROCEDURE FOR PH METER TESTING AND CALIBRATION\" for pH monitoring. Even setting aside the scientific inadequacy of pH as a standalone control, several deficiencies were identified in how you monitor and verify pH in practice:\u003C\u002Fp>\u003Cul>\u003Cli>The SOP does not clearly indicate when pH verification occurs in relation to fermentation completion, cold storage (\u003Cstrong>(b)(4)\u003C\u002Fstrong> days), or packaging operations. Additionally, your “pH Measurement Log (Daily)” records do not indicate what time pH measurements were taken, such that it is not possible to determine whether monitoring is occurring at meaningful or consistent points in the process.\u003C\u002Fli>\u003Cli>Contrary to the SOP, your actual pH testing practice is to collect a sample from the \u003Cstrong>(b)(4)\u003C\u002Fstrong> barrel after fermentation is completed \u003Cstrong>(b)(4)\u003C\u002Fstrong> moving the barrel to the cooler. \u003Cstrong>(b)(4)\u003C\u002Fstrong> of a large barrel does not constitute a representative sample of the batch and does not adequately characterize the pH of the product as a whole. The RTE fermented cabbage is packaged into finished product containers approximately \u003Cstrong>(b)(4)\u003C\u002Fstrong> days \u003Cstrong>(b)(4)\u003C\u002Fstrong> processing, and you stated you do not test pH at the time of packaging. Given the time elapsed between initial pH measurement and packaging, the absence of pH testing at packaging represents a gap in your ability to verify that the product meets the established critical limit prior to distribution.\u003C\u002Fli>\u003Cli>The SOP indicates the pH meter should be calibrated \u003Cstrong>(b)(4)\u003C\u002Fstrong>, or whenever readings are in doubt. However, your pH calibration records show the meter is only calibrated \u003Cem>once per week\u003C\u002Fem>, at the beginning of each week.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>You have not provided a validation study or supporting scientific literature demonstrating that your fermentation process—including all applicable \u003Cstrong>(b)(4)\u003C\u002Fstrong>—adequately controls the pathogens of concern. Validation approaches such as a challenge study may be used to demonstrate that the \u003Cstrong>(b)(4)\u003C\u002Fstrong> achieves adequate process preventive control. Additionally, if you can consistently demonstrate that the finished packaged product achieves and maintains a pH of ≤ 4.2, this would provide an additional safety margin by keeping the product well below the minimum inhibitory pH threshold for \u003Cem>Clostridium botulinum\u003C\u002Fem>. As adequate controls are developed, you must also ensure that appropriate preventive control management components—including monitoring, corrective actions, and verification procedures—are established and implemented in accordance with 21 CFR Part 117, Subpart C.\u003C\u002Fp>\u003Cp>\u003Cstrong>\u003Cu>Misbranding\u003C\u002Fu>\u003C\u002Fstrong>\u003Cbr>1. Your Russian Style Kvas Drink product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required by 21 CFR 101.4(a)(1). Specifically, your Russian Style Kvas Drink product label declares the ingredient “\u003Cstrong>(b)(4)\u003C\u002Fstrong>”, which is not the common or usual name of the ingredient.\u003C\u002Fp>\u003Cp>2. Your Russian Style Kvas Drink product is misbranded within the meaning of Section 403(f) of the Act [21 U.S. C. 343(f)] because the label bears a foreign language (Russian)but does not repeat all required labeling information in the foreign language (Russian). The mandatory label information is present in English, but the label does not repeat all required information in Russian, as required by 21 CFR 101.15(c)(2).\u003C\u002Fp>\u003Cp>3. Your Russian Style Kvas Drink product is misbranded within the meaning of Section 403(q) of the Act [21 U.S. C. 343(q)] because the Nutrition Facts label is not in accordance with the requirements under 21 CFR 101.9. For example, the Nutrition Facts label lacks declaration for added sugars, and the required vitamins and minerals, vitamin D and potassium, as required by 21 CFR 101.9(c).\u003C\u002Fp>\u003Cp>4. Your Sour Cabbage and Half Sour Pickles products are misbranded within the meaning of section 403(e)(2) [21 U.S.C. §343(e)(2)] of the Act. Specifically:\u003C\u002Fp>\u003Cp>a. Your Sour Cabbage product label declares the net quantity of contents in terms of weight; however, it must be declared in terms of fluid measure, as required in 21 CFR 101.7(a).\u003C\u002Fp>\u003Cp>b. Your Half Sour Pickles product label declares the net quantity of contents as ‘32 FL OZ’ but fails to include the largest whole unit of liquid measure in parentheses. Because 32 fluid ounces equals one quart, the declaration must be expressed as ‘32 fl oz (1 qt),’ as required by 21 CFR 101.7(j)(1) and shown in 21 CFR 101.7(m)(3).\u003C\u002Fp>\u003Cp>This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including applicable FDA regulations.\u003C\u002Fp>\u003Cp>This letter notifies you of our concerns and provides you with an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and\u002For injunction.\u003C\u002Fp>\u003Cp>\u003Cstrong>In addition to the violations described above, we offer the following comments:\u003C\u002Fstrong>\u003C\u002Fp>\u003Cul>\u003Cli>Your Half Sour Pickles and Russian Style Kvas Drink product labels do not include the street address of the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(d). We note, however, that the street address may be omitted if it is shown in a current city directory or telephone directory.\u003C\u002Fli>\u003Cli>Your Sour Cabbage product label identifies the firm's name and place of business; however, it does not include an appropriate qualifying phrase (e.g., \"Distributed by\") in conjunction with the place of business as required under 21 CFR 101.5(c). Although the statement \"Distributed by RDM Express Inc.\" appears toward the bottom of the label, it does not appear to be part of the place of business declaration, and it is unclear whether this statement is intended to satisfy the requirements of 21 CFR 101.5(c).\u003C\u002Fli>\u003Cli>The net quantity of contents for your Half Sour Pickles product uses the term “Net Wt.” in conjunction with a declaration expressed in fluid measure (i.e., fl. oz). We note that 21 CFR 101.7(j)(3) provides that the use of the terms “net” or “net contents” in terms of fluid measure is optional.\u003C\u002Fli>\u003Cli>The common or usual name \"Russian Style Kvas Drink\" may not satisfy the requirements of 21 CFR 101.3(b)(2). A more descriptive term, in accordance with 21 CFR 101.3(b)(3), may be more appropriate to accurately convey the nature of this product as a Russian style malt-based drink and ensure and ensure consumers have a clear understanding of what they are purchasing.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\u003Cp>Your written response should be sent electronically to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Clarice J. Ahn, Compliance Officer, at Clarice.Ahn@fda.hhs.gov. If you have any questions regarding this letter, you may contact Clarice J. Ahn, Compliance Officer, at Clarice.Ahn@fda.hhs.gov. Please reference CMS #729223 on any submissions and within the subject line of any emails to us.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Maria S. Knirk, JD MBA\u003Cbr>Director, Office of Enforcement\u003Cbr>Office of Compliance and Enforcement\u003Cbr>Human Foods Program\u003C\u002Fp>\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA Electronic Mail\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nMr. Boris Dinerman\n\nRecipient Title\n\nCEO\n\nRDM Express Inc.\n\n2000 McKinnon Ave Bldg 427, Unit #12\n\nSan Francisco, CA 94124\n\nUnited States\n\n(b)(6), (b)(7)(C)\n\nIssuing Office:\n\nHuman Foods Program\n\nUnited States\n\nSeptember 11, 2026\nWARNING LETTER\nRe: CMS #729223\nDear Mr. Dinerman:\nThe United States Food and Drug Administration (FDA) inspected your manufacturing facility, located at 2000 McKinnon Ave, Bldg 427, Unit #12, San Francisco, CA 94124, between February 18, 2026, and March 10, 2026. During our inspection of your facility, an FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Based on FDA's inspectional findings and analytical results for finished product samples of your Fermented Cabbage, we have determined that your ready-to-eat (RTE) Fermented Cabbage\u002FSour Cabbage products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and FDA's regulations through links on FDA's website at www.fda.gov.\nFurther, a review of the Russian Style Kvas Drink, Sour Cabbage, and Half Sour Pickles product labels collected during the inspection revealed significant violations of the labeling regulations for foods under 21 CFR Part 101. These violations render your product to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], as discussed below.\nAt the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations. To date, FDA has not received your written response. After reviewing the inspectional findings, we are issuing this letter to advise you of FDA’s concerns.\nHazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)\n1. You did not identify and evaluate known or reasonably foreseeable hazards to determine whether they required preventive controls, as required by 21 CFR 117.130(a)(1).\nSpecifically, you manufacture a refrigerated, RTE Fermented Cabbage\u002FSour Cabbage product. However, the hazard analysis in your document titled “Food Safety Plan for Acidified & Fermented Foods” dated April 30, 2025, did not identify and evaluate the following hazards requiring a preventive control:\na. Recontamination with environmental pathogens (e.g., Listeria monocytogenes)\nEmployees (b)(4) package Fermented Cabbage\u002FSour Cabbage into (b)(4) pails and (b)(4) containers in the production room, under ambient conditions, exposing RTE product to the environment. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. A knowledgeable person manufacturing\u002Fprocessing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control (e.g., sanitation controls). Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR 117.135(c)(3)).\nYou have a document titled “PROCEDURE FOR CLEANING AND SANITIZING OF EQUIPMENT” which, among other things, lists steps such as (b)(4), washing, rinsing, (b)(4) drying. However, this document does not include procedures for monitoring, corrective actions, and verification.\nFurthermore, you provided copies of your “Sanitation Checklist”, “Sanitation Log”, and “Deep Cleaning Checklist”. However, none of these documents identify what equipment was cleaned and sanitized or who performed the cleaning.\nFurthermore, you provided a copy of your “Hygiene Checklist” which indicates that you monitor for glove use and handwashing (b)(4). This frequency is insufficient to ensure that the hazard of pathogen contamination is controlled during production of fermented cabbage. Additionally, this “Hygiene Checklist” includes a “Compliant” column, which was marked “N” (no) by an employee with initials “(b)(4)” for (b)(4) dates recorded between October 27, 2025 and February 23, 2026. However, there is no documentation identifying the cause of non-compliance or any corrective actions taken in response.\nNone of the above-mentioned records were reviewed for completeness and accuracy within seven working days of the records being created, as required under 21 CFR 117.165(a)(4).\nLastly, you do not have an environmental monitoring program, nor do you conduct any environmental monitoring to verify that your sanitation procedures are effectively controlling the hazard of environmental pathogens, such as Listeria monocytogenes.\nb. Parasites (e.g., Cyclospora) and viruses (e.g., Norovirus and Hepatitis A) in (b)(4) cranberries\nYou receive (b)(4) cranberries, which is an ingredient used in your refrigerated, RTE Fermented Cabbage\u002FSour Cabbage product. Cranberries, like other berries, have been associated with parasites such as Cyclospora and viruses such as Norovirus and Hepatitis A. Oocysts of Cyclospora can be shed by infected hosts during harvesting, and depending on time and temperature, (b)(4) may not be effective in appropriately destroying Cyclospora. Similarly, Norovirus and Hepatitis A are known to persist on berry surfaces and are not reliably inactivated by (b)(4). Your fermentation process does not appear adequate to control the hazard of growth and\u002For survival of parasites, such as Cyclospora, and viruses, such as Norovirus and Hepatitis A, if they are already present in the (b)(4) cranberries at receiving. Additionally, your product’s formulation does not provide an adequate “kill step” for Norovirus, Hepatitis A, or Cyclospora. Finally, the (b)(4) cranberries are used in a RTE application and do not undergo a validated lethality step. A knowledgeable person manufacturing\u002Fprocessing food in your circumstances would identify the above-mentioned parasites and viruses as a hazard requiring a preventive control (e.g., a supply-chain control) in this ingredient. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control due to a hazard must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR 117.410).\n2. Your written process preventive control, monitoring, and verification procedures were not appropriate to significantly minimize or prevent hazards requiring preventive controls, as required by 21 CFR 117.135(c)(1).\nSpecifically, your document titled “Food Safety Plan for Acidified & Fermented Foods” dated April 30, 2025, identifies a “preventive measure” of “Finished product pH below (b)(4)” to control the hazard of “Pathogens: Clostridium botulinum, Listeria monocytogenes” at your “pH Testing ((b)(4))” step. However, we note that pH alone is insufficient to control all relevant pathogens of concern. While reducing pH before packaging may limit pathogen growth, your process preventive control must also account for pathogen survival. Listeria monocytogenes is an acid-tolerant pathogen that can survive the fermentation process if introduced through raw ingredients or environmental contamination, and may persist even at a pH of (b)(4). Similarly, product formulation alone does not prevent or eliminate vegetative bacterial pathogens—such as Listeria, E. coli, and Salmonella—that may be associated with incoming raw ingredients.\nOn February 25, 2026, FDA collected a sample of RTE fermented cabbage from your facility (sample # 1319005) and found and pH range of 4.0-4.17, a range at which Listeria monocytogenes is known to survive, and a water activity of 0.98. This water activity level represents an optimal moisture environment for bacteria to survive or thrive, further demonstrating that pH alone does not constitute an adequate preventive control when other intrinsic factors remain permissive for pathogen survival and growth.\nFurthermore, your written process preventive control document titled “Critical Control Point (CCP) Chart” references an SOP titled \"PROCEDURE FOR PH METER TESTING AND CALIBRATION\" for pH monitoring. Even setting aside the scientific inadequacy of pH as a standalone control, several deficiencies were identified in how you monitor and verify pH in practice:\nThe SOP does not clearly indicate when pH verification occurs in relation to fermentation completion, cold storage ((b)(4) days), or packaging operations. Additionally, your “pH Measurement Log (Daily)” records do not indicate what time pH measurements were taken, such that it is not possible to determine whether monitoring is occurring at meaningful or consistent points in the process.\nContrary to the SOP, your actual pH testing practice is to collect a sample from the (b)(4) barrel after fermentation is completed (b)(4) moving the barrel to the cooler. (b)(4) of a large barrel does not constitute a representative sample of the batch and does not adequately characterize the pH of the product as a whole. The RTE fermented cabbage is packaged into finished product containers approximately (b)(4) days (b)(4) processing, and you stated you do not test pH at the time of packaging. Given the time elapsed between initial pH measurement and packaging, the absence of pH testing at packaging represents a gap in your ability to verify that the product meets the established critical limit prior to distribution.\nThe SOP indicates the pH meter should be calibrated (b)(4), or whenever readings are in doubt. However, your pH calibration records show the meter is only calibrated once per week, at the beginning of each week.\nYou have not provided a validation study or supporting scientific literature demonstrating that your fermentation process—including all applicable (b)(4)—adequately controls the pathogens of concern. Validation approaches such as a challenge study may be used to demonstrate that the (b)(4) achieves adequate process preventive control. Additionally, if you can consistently demonstrate that the finished packaged product achieves and maintains a pH of ≤ 4.2, this would provide an additional safety margin by keeping the product well below the minimum inhibitory pH threshold for Clostridium botulinum. As adequate controls are developed, you must also ensure that appropriate preventive control management components—including monitoring, corrective actions, and verification procedures—are established and implemented in accordance with 21 CFR Part 117, Subpart C.\nMisbranding\n1. Your Russian Style Kvas Drink product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required by 21 CFR 101.4(a)(1). Specifically, your Russian Style Kvas Drink product label declares the ingredient “(b)(4)”, which is not the common or usual name of the ingredient.\n2. Your Russian Style Kvas Drink product is misbranded within the meaning of Section 403(f) of the Act [21 U.S. C. 343(f)] because the label bears a foreign language (Russian)but does not repeat all required labeling information in the foreign language (Russian). The mandatory label information is present in English, but the label does not repeat all required information in Russian, as required by 21 CFR 101.15(c)(2).\n3. Your Russian Style Kvas Drink product is misbranded within the meaning of Section 403(q) of the Act [21 U.S. C. 343(q)] because the Nutrition Facts label is not in accordance with the requirements under 21 CFR 101.9. For example, the Nutrition Facts label lacks declaration for added sugars, and the required vitamins and minerals, vitamin D and potassium, as required by 21 CFR 101.9(c).\n4. Your Sour Cabbage and Half Sour Pickles products are misbranded within the meaning of section 403(e)(2) [21 U.S.C. §343(e)(2)] of the Act. Specifically:\na. Your Sour Cabbage product label declares the net quantity of contents in terms of weight; however, it must be declared in terms of fluid measure, as required in 21 CFR 101.7(a).\nb. Your Half Sour Pickles product label declares the net quantity of contents as ‘32 FL OZ’ but fails to include the largest whole unit of liquid measure in parentheses. Because 32 fluid ounces equals one quart, the declaration must be expressed as ‘32 fl oz (1 qt),’ as required by 21 CFR 101.7(j)(1) and shown in 21 CFR 101.7(m)(3).\nThis letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including applicable FDA regulations.\nThis letter notifies you of our concerns and provides you with an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and\u002For injunction.\nIn addition to the violations described above, we offer the following comments:\nYour Half Sour Pickles and Russian Style Kvas Drink product labels do not include the street address of the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(d). We note, however, that the street address may be omitted if it is shown in a current city directory or telephone directory.\nYour Sour Cabbage product label identifies the firm's name and place of business; however, it does not include an appropriate qualifying phrase (e.g., \"Distributed by\") in conjunction with the place of business as required under 21 CFR 101.5(c). Although the statement \"Distributed by RDM Express Inc.\" appears toward the bottom of the label, it does not appear to be part of the place of business declaration, and it is unclear whether this statement is intended to satisfy the requirements of 21 CFR 101.5(c).\nThe net quantity of contents for your Half Sour Pickles product uses the term “Net Wt.” in conjunction with a declaration expressed in fluid measure (i.e., fl. oz). We note that 21 CFR 101.7(j)(3) provides that the use of the terms “net” or “net contents” in terms of fluid measure is optional.\nThe common or usual name \"Russian Style Kvas Drink\" may not satisfy the requirements of 21 CFR 101.3(b)(2). A more descriptive term, in accordance with 21 CFR 101.3(b)(3), may be more appropriate to accurately convey the nature of this product as a Russian style malt-based drink and ensure and ensure consumers have a clear understanding of what they are purchasing.\nPlease notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.\nYour written response should be sent electronically to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Clarice J. Ahn, Compliance Officer, at Clarice.Ahn@fda.hhs.gov. If you have any questions regarding this letter, you may contact Clarice J. Ahn, Compliance Officer, at Clarice.Ahn@fda.hhs.gov. Please reference CMS #729223 on any submissions and within the subject line of any emails to us.\nSincerely,\n\u002FS\u002F\nMaria S. Knirk, JD MBA\nDirector, Office of Enforcement\nOffice of Compliance and Enforcement\nHuman Foods Program","2026-10-14T12:32:21.242+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2026-10-13T04:00:00Z\">10\u002F13\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-09-11T04:00:00Z\">09\u002F11\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Frdm-express-inc-729223-09112026\">RDM Express Inc.\u003C\u002Fa>","","2026-10-14T12:31:16.41489+00:00","2026-10-14T14:44:01.489557+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"event_backfill":34,"pma":35,"warning_letter":36},"2026-10-12T02:00:50.914+00:00","2026-10-12T02:00:38.521+00:00","2026-10-12T02:00:45.002+00:00","2026-10-14T04:02:53.8+00:00","2026-09-07T05:17:28.839+00:00","2026-10-12T02:00:52.377+00:00","2026-10-14T14:44:02.318+00:00"]