[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-longford-water-company-llc-708114-11132025":3,"fda-latest-sync-dates":30},{"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":28,"updated_at":29},411,"longford-water-company-llc-708114-11132025","Warning Letter","Longford Water Company LLC",null,"Office of Compliance and Enforcement","Processing & Bottling of Bottled Drinking Water Regulations\u002FAdulterated","2025-12-16","2025-11-13","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Flongford-water-company-llc-708114-11132025","708114","Food & Beverages","VIA Dispatch","Catherine M Girton","\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 Dispatch\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\">Catherine M Girton\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\">Owner\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Longford Water Company LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">526 Santa Fe Ave\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Longford\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">KS\u003C\u002Fspan> \u003Cspan class=\"postal-code\">67458\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:cgirton@longfordwater.com\"> cgirton@longfordwater.com\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>Office of Compliance and Enforcement\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>November 13, 2025\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp class=\"text-align-center\">Re: CMS Case #708114\u003C\u002Fp>\u003Cp>\u003Cbr>Dear Ms. Catherine Girton:\u003C\u002Fp>\u003Cp>On March 17-18, 2025, the United States Food and Drug Administration (FDA) conducted an inspection of your bottled water facility, located at 526 Santa Fe Ave, Longford, KS 67458. During our inspection of your facility, the FDA investigators findings revealed serious violations of the Processing and Bottling of Bottled Drinking Water Regulations, Title 21, Code of Federal Regulations (21 CFR), Part 129. These violations render the bottle water products processed at your facility 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), because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You may find the Act and FDA’s regulations through links on FDA’s Internet home page at www.fda.gov.\u003C\u002Fp>\u003Cp>We acknowledge receipt of your response to the Form FDA 483, Inspectional Observations, via email dated March 19, 2025, March 24, 2025, and March 27, 2025, received by our office. Details of FDA’s review of these responses are listed below.\u003C\u002Fp>\u003Cp>Your significant violations were as follows:\u003C\u002Fp>\u003Cp>1. You failed to ensure the treatment of product water by \u003Cstrong>(b)(4)\u003C\u002Fstrong> is done in a manner effective in accomplishing its intended purpose and in accordance with section 409 of the Act, as required by 21 CFR 129.80(a).\u003C\u002Fp>\u003Cp>Specifically, during start-up of production, you check the \u003Cstrong>(b)(4)\u003C\u002Fstrong> meter to make sure that it is not below \u003Cstrong>(b)(4)\u003C\u002Fstrong>ppm \u003Cstrong>(b)(4)\u003C\u002Fstrong> or above \u003Cstrong>(b)(4)\u003C\u002Fstrong>ppm \u003Cstrong>(b)(4)\u003C\u002Fstrong>, or that the pump is turned off. The \u003Cstrong>(b)(4)\u003C\u002Fstrong> parameters used were futher described by your plant manager as \u003Cstrong>(b)(4)\u003C\u002Fstrong>ppm in an enclosed system for \u003Cstrong>(b)(4)\u003C\u002Fstrong> minutes. However, you could not provide any data or information showing this water treatment process using \u003Cstrong>(b)(4)\u003C\u002Fstrong> is effective in accomplishing its intended purpose of water sanitation. Furthermore, you do not maintain records of the performance (e.g., \u003Cstrong>(b)(4)\u003C\u002Fstrong> concentration and treatment duration) and effectiveness of your \u003Cstrong>(b)(4)\u003C\u002Fstrong> treatment, nor do you collect product water samples after processing and prior to bottling to demonstrate your \u003Cstrong>(b)(4)\u003C\u002Fstrong> treatment process results in a maximum residual level at the time of bottling that does not exceed 0.4 mg\u002FL, as required by 21 CFR 184.1563.\u003C\u002Fp>\u003Cp>In your written response, dated March 24, 2025, you provided a certificate of analysis for total coliforms and \u003Cem>E. coli\u003C\u002Fem> testing on one sample water collected prior to filling; however, you did not provide any records of the \u003Cstrong>(b)(4)\u003C\u002Fstrong> concentration and treatment duration, details about how you plan to collect and analyze this type of sample, or training records associated with any updated program. You also did not provide any information on the effectiveness of your \u003Cstrong>(b)(4)\u003C\u002Fstrong> treatment process for its intended purpose of water sanitation.\u003C\u002Fp>\u003Cp>2. You failed to conduct and analyze at least once a week for bacteriological purposes a representative sample from a batch or segment of a continuous production run for each type of bottled drinking water produced during a day's production, as required by 21 CFR 129.80(g)(1).\u003C\u002Fp>\u003Cp>Specifically \u003Cstrong>(b)(4)\u003C\u002Fstrong>. However, you produce different types of drinking water, including Purified Drinking Water and Drinking Water; you use \u003Cstrong>(b)(4)\u003C\u002Fstrong> different production lines; and you do not sample each type of bottled water at least once a week.\u003Cbr>Furthermore, you do not dechlorinate the sample collected prior to testing as indicated in the directions for use for the test.\u003C\u002Fp>\u003Cp>In your written response, dated March 24, 2025, you provided an updated log which provides a space to fill in for the \u003Cstrong>(b)(4)\u003C\u002Fstrong> step and for collected bottle sizes. However, you have not demonstrated that you are testing each type of bottled water and did not provide a procedure explaining the \u003Cstrong>(b)(4)\u003C\u002Fstrong> step or the implementation of this process.\u003C\u002Fp>\u003Cp>3. You failed to sample and inspect containers and closures, which includes making a bacteriological swab and\u002For rinse count at least once each quarter from at least four containers and closures selected just prior to filling and sealing, to ensure they are free from contamination, as required by 21 CFR 129.80(f).\u003C\u002Fp>\u003Cp>Specifically, you stated you do not conduct any testing of your containers or closures.\u003C\u002Fp>\u003Cp>In your written response, dated March 27, 2025, you stated you are still researching appropriate corrective actions.\u003C\u002Fp>\u003Cp>4. You do not clean and adequately sanitize product water-contact surfaces of all multiservice containers, utensils, pipes, and equipment used in the transportation, processing, handling, and storage of product water, as required by 21 CFR 129.37(a). Specifically, you do not clean all your product water contact utensils or equipment. You conduct sanitizing with \u003Cstrong>(b)(4)\u003C\u002Fstrong>ppm chlorine \u003Cstrong>(b)(4)\u003C\u002Fstrong> a month. Furthermore, you do not keep complete records for your \u003Cstrong>(b)(4)\u003C\u002Fstrong> operations.\u003C\u002Fp>\u003Cp>In your written responses, dated March 19, 2025 and March 24, 2025, you provided an updated monthly \u003Cstrong>(b)(4)\u003C\u002Fstrong>. The updated log contains limited information for \u003Cstrong>(b)(4)\u003C\u002Fstrong> and indicates that you are now using “\u003Cstrong>(b)(4)\u003C\u002Fstrong> soap for \u003Cstrong>(b)(4)\u003C\u002Fstrong>, and indicates you used \u003Cstrong>(b)(4)\u003C\u002Fstrong> ppm \u003Cstrong>(b)(4)\u003C\u002Fstrong>” for \u003Cstrong>(b)(4)\u003C\u002Fstrong>. The log lists some product water contact surfaces for the “\u003Cstrong>(b)(4)\u003C\u002Fstrong>”, and other surfaces of the “\u003Cstrong>(b)(4)\u003C\u002Fstrong>” equipment and the “\u003Cstrong>(b)(4)\u003C\u002Fstrong>”. However, the updated form does not include all product water contact surfaces, such as the product water lines, nor does it include duration of treatment. Furthermore, your \u003Cstrong>(b)(4)\u003C\u002Fstrong> log for the \u003Cstrong>(b)(4)\u003C\u002Fstrong> does not include the duration of treatment. Also, you did not provide associated updated SOPs for \u003Cstrong>(b)(4)\u003C\u002Fstrong> in your response.\u003C\u002Fp>\u003Cp>Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps and corrections you have taken and 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>This letter notifies you of our concerns and provides you an opportunity to address them. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.\u003C\u002Fp>\u003Cp>Your written response should be sent electronically to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Andrew Hoopes, Compliance Officer, at Andrew.Hoopes@fda.hhs.gov. Please include reference CMS Case #708114 on any submissions and within the subject line of any email correspondence to the agency. If you have questions regarding this letter, please contact Andrew Hoopes, Compliance Officer, at Andrew.Hoopes@fda.hhs.gov.\u003Cbr>\u003Cbr>Sincerely,\u003C\u002Fp>\u003Cp>\u002Fs\u002F\u003Cbr>Maria S. Knirk, JD MBA Acting Director\u003Cbr>Office of Enforcement\u003Cbr>Office of Compliance and Enforcement 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 Dispatch\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nCatherine M Girton\n\nRecipient Title\n\nOwner\n\nLongford Water Company LLC\n\n526 Santa Fe Ave\n\nLongford, KS 67458\n\nUnited States\n\ncgirton@longfordwater.com\n\nIssuing Office:\n\nOffice of Compliance and Enforcement\n\nUnited States\n\nNovember 13, 2025\nWARNING LETTER\nRe: CMS Case #708114\n\nDear Ms. Catherine Girton:\nOn March 17-18, 2025, the United States Food and Drug Administration (FDA) conducted an inspection of your bottled water facility, located at 526 Santa Fe Ave, Longford, KS 67458. During our inspection of your facility, the FDA investigators findings revealed serious violations of the Processing and Bottling of Bottled Drinking Water Regulations, Title 21, Code of Federal Regulations (21 CFR), Part 129. These violations render the bottle water products processed at your facility 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), because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You may find the Act and FDA’s regulations through links on FDA’s Internet home page at www.fda.gov.\nWe acknowledge receipt of your response to the Form FDA 483, Inspectional Observations, via email dated March 19, 2025, March 24, 2025, and March 27, 2025, received by our office. Details of FDA’s review of these responses are listed below.\nYour significant violations were as follows:\n1. You failed to ensure the treatment of product water by (b)(4) is done in a manner effective in accomplishing its intended purpose and in accordance with section 409 of the Act, as required by 21 CFR 129.80(a).\nSpecifically, during start-up of production, you check the (b)(4) meter to make sure that it is not below (b)(4)ppm (b)(4) or above (b)(4)ppm (b)(4), or that the pump is turned off. The (b)(4) parameters used were futher described by your plant manager as (b)(4)ppm in an enclosed system for (b)(4) minutes. However, you could not provide any data or information showing this water treatment process using (b)(4) is effective in accomplishing its intended purpose of water sanitation. Furthermore, you do not maintain records of the performance (e.g., (b)(4) concentration and treatment duration) and effectiveness of your (b)(4) treatment, nor do you collect product water samples after processing and prior to bottling to demonstrate your (b)(4) treatment process results in a maximum residual level at the time of bottling that does not exceed 0.4 mg\u002FL, as required by 21 CFR 184.1563.\nIn your written response, dated March 24, 2025, you provided a certificate of analysis for total coliforms and E. coli testing on one sample water collected prior to filling; however, you did not provide any records of the (b)(4) concentration and treatment duration, details about how you plan to collect and analyze this type of sample, or training records associated with any updated program. You also did not provide any information on the effectiveness of your (b)(4) treatment process for its intended purpose of water sanitation.\n2. You failed to conduct and analyze at least once a week for bacteriological purposes a representative sample from a batch or segment of a continuous production run for each type of bottled drinking water produced during a day's production, as required by 21 CFR 129.80(g)(1).\nSpecifically (b)(4). However, you produce different types of drinking water, including Purified Drinking Water and Drinking Water; you use (b)(4) different production lines; and you do not sample each type of bottled water at least once a week.\nFurthermore, you do not dechlorinate the sample collected prior to testing as indicated in the directions for use for the test.\nIn your written response, dated March 24, 2025, you provided an updated log which provides a space to fill in for the (b)(4) step and for collected bottle sizes. However, you have not demonstrated that you are testing each type of bottled water and did not provide a procedure explaining the (b)(4) step or the implementation of this process.\n3. You failed to sample and inspect containers and closures, which includes making a bacteriological swab and\u002For rinse count at least once each quarter from at least four containers and closures selected just prior to filling and sealing, to ensure they are free from contamination, as required by 21 CFR 129.80(f).\nSpecifically, you stated you do not conduct any testing of your containers or closures.\nIn your written response, dated March 27, 2025, you stated you are still researching appropriate corrective actions.\n4. You do not clean and adequately sanitize product water-contact surfaces of all multiservice containers, utensils, pipes, and equipment used in the transportation, processing, handling, and storage of product water, as required by 21 CFR 129.37(a). Specifically, you do not clean all your product water contact utensils or equipment. You conduct sanitizing with (b)(4)ppm chlorine (b)(4) a month. Furthermore, you do not keep complete records for your (b)(4) operations.\nIn your written responses, dated March 19, 2025 and March 24, 2025, you provided an updated monthly (b)(4). The updated log contains limited information for (b)(4) and indicates that you are now using “(b)(4) soap for (b)(4), and indicates you used (b)(4) ppm (b)(4)” for (b)(4). The log lists some product water contact surfaces for the “(b)(4)”, and other surfaces of the “(b)(4)” equipment and the “(b)(4)”. However, the updated form does not include all product water contact surfaces, such as the product water lines, nor does it include duration of treatment. Furthermore, your (b)(4) log for the (b)(4) does not include the duration of treatment. Also, you did not provide associated updated SOPs for (b)(4) in your response.\nPlease notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps and corrections you have taken and 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.\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.\nYour written response should be sent electronically to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Andrew Hoopes, Compliance Officer, at Andrew.Hoopes@fda.hhs.gov. Please include reference CMS Case #708114 on any submissions and within the subject line of any email correspondence to the agency. If you have questions regarding this letter, please contact Andrew Hoopes, Compliance Officer, at Andrew.Hoopes@fda.hhs.gov.\n\nSincerely,\n\u002Fs\u002F\nMaria S. Knirk, JD MBA Acting Director\nOffice of Enforcement\nOffice of Compliance and Enforcement Human Foods Program","2026-08-19T16:09:07.425+00:00",[23,24,25,9,26,27,27,27],"\u003Ctime datetime=\"2025-12-16T05:00:00Z\">12\u002F16\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-11-13T05:00:00Z\">11\u002F13\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Flongford-water-company-llc-708114-11132025\">Longford Water Company LLC\u003C\u002Fa>","Processing & Bottling of Bottled Drinking Water Regulations\u002FAdulterated\u003Cbr \u002F>\r\n","","2026-08-18T06:42:28.498414+00:00","2026-08-20T02:24:55.726997+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"pma":35,"warning_letter":36},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]