Rama Food Manufacture Corp.

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September 22, 2026

WARNING LETTER

Re: CMS #730689

Dear Ms. Ving and Mr. Ving:

The United States Food and Drug Administration (FDA) inspected two of your Rama Food Manufacture Corp. food manufacturing facilities located at 1486 E Cedar Street, Ontario, California 91761 and 2131 S Parco Avenue, Ontario, California 91761 from January 27 through February 26, 2026. Both facilities manufacture ready-to-eat (RTE) rice noodles (various noodle sizes/types).

During our inspections, FDA investigators observed 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). Additionally, FDA collected environmental samples (i.e., swabs) from various areas in both facilities. FDA laboratory analysis of the environmental swabs found the presence of Listeria innocua and grayi in your S Parco Avenue facility and L. grayi in your E Cedar Street facility, which are non-human pathogenic Listeria spp. FDA also collected four finished product samples and analyzed them for water activity and pH.

Based on FDA’s inspectional findings and analytical results for finished product samples of Pad Thai Rice Stick Noodle, Fresh Rice Stick Noodle Banh Pho Tuoi, and Rice Stick Noodle Big Cut Noodle, we have determined that the RTE rice noodle products manufactured in both of your facilities 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)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or 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 control 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 further information about the CGMP & PC rule through links on FDA’s website at http://www.fda.gov.

At the conclusion of both inspections, the FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations to each facility. We received your written responses to both FDA-483s on March 17, 2026, describing your planned and implemented corrective actions. Based on our review of the inspectional and analytical findings and your responses, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at each of your facilities. We discuss your responses below.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):

E Cedar Street Facility

1. Your written process preventive control procedures were not appropriate to significantly minimize or prevent hazards requiring preventive controls, as required by 21 CFR 117.135(c)(1). Your facility’s written hazard analysis determined that pathogen hazards such as Bacillus cereus (B. cereus), Salmonella, Listeria monocytogenes (L. monocytogenes), and Clostridium botulinum (C. botulinum) required a preventive control. The “Preventive Controls” section of your food safety plan document indicates that such hazards will be significantly minimized or prevented at the rice (b)(4) to rice (b)(4), rice (b)(4), (b)(4), and (b)(4) processing steps. However, a review of your established control methods/critical limits for these process preventive controls determined that they may not control the hazards. Additionally, in some cases, monitoring of these parameters was not implemented and/or the parameters were not met. Specifically,

a. (b)(4): Your “Temperature Control of Rice (b)(4) Tank” process preventive control covering rice (b)(4) to rice (b)(4) in your food safety plan lists a critical limit of “Rice (b)(4) Temperature ≤ (b)(4)” to be checked “Every (b)(4)” which does not provide sufficient control for the hazard of B. cereus identified at these processing steps. If the (b)(4) rice is exposed to temperatures above 70°F for more than three hours cumulatively, pathogens such as B. cereus can grow and produce toxin. FDA recommends referencing Appendix 3, Table 3-B of our Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, which explains that for the potential hazardous conditions of growth and toxin formation of B. cereus, the recommended maximum cumulative exposure time for product temperatures above 70°F is three hours.

Your response to the FDA-483 dated March 17, 2026, included updated time and temperature critical limits for the process preventive control covering the rice (b)(4) and rice (b)(4) steps (b)(4). As written, your critical limits of (b)(4) process ≤ (b)(4) rice temperature ≤ (b)(4), (b)(4) process ≤ (b)(4), and (b)(4) rice temperature ≤ (b)(4) would still allow the soaked and ground rice to be exposed to temperatures above 70°F for up to 3.5 hours cumulatively, which does not appear to provide adequate control for the hazard of B. cereus. Your response also referenced a proposed challenge study as the basis for these critical limits and stated that the results of the study would be provided upon completion. To date, you have not provided additional information to the Agency regarding this issue.

b. (b)(4): Your “pH Control of Rice (b)(4)” process preventive control (b)(4) in your food safety plan lists a critical limit of “Rice (b)(4)” which may not provide sufficient control for the hazard of pathogen growth and toxin formation, such as B. cereus, identified at this processing step. Your firm stated that (b)(4) were also added to control for B. cereus; however, you had no written process preventive control for the addition of (b)(4). The rice (b)(4) is (b)(4) before being (b)(4) and packaged, exposing the noodles to elevated temperatures for extended periods of time which may allow for the growth of pathogens and/or toxin formation, such as B. cereus.

On February 12, 2026, our investigators measured the temperature of in-process RTE rice noodle sheets, Lot (b)(4), from Lines (b)(4) and (b)(4) at the (b)(4) step at (b)(4) and (b)(4) around 9:20 AM. After (b)(4), the rice noodle sheets were (b)(4) approximately (b)(4). A (b)(4) was placed on the stacked sheets, and a fan was blowing on the rice sheets during the (b)(4) process. At 10:38 AM, the rice noodle sheet temperature measured at 87°F and 87.5°F. At 3:30 PM, our investigators measured the rice noodle sheet temperatures from each line at 80°F and 81.5°F, respectively. The temperatures of rice noodle sheets were above 70°F for 6 hours and 10 minutes when this process was observed during the inspection.

Your response to the FDA-483 indicated the use of pH control and (b)(4) in the rice (b)(4) to control for the hazards of B. cereus and C. perfringens at “(b)(4).” However, the letter you provided from (b)(4) noted “A product-specific validation (e.g. (b)(4)) for B. cereus is recommended to specifically support the Food Safety Plan for its control in the noodle process.” You indicated that you were planning a validation study for product (b)(4) with your microbiological consultant and that you would submit the results once completed. To date, you have not provided such a validation study to the Agency.

Additionally, we note that you have not identified the cooling of the cooked rice noodle sheets (b)(4) as requiring a process preventive control and have not implemented monitoring procedures to ensure the RTE rice noodle sheets are cooled quickly enough to adequately control bacterial growth and/or toxin formation during cooling. FDA recommends in the Food Code cooling from 57ºC (135ºF) to 21ºC (70°F) within 2 hours and then further cooling to 5ºC (41°F) within a total of six hours. The cooling time to reduce temperatures to 21ºC (70°F) is important to ensure products are cooled quickly through the optimum temperatures for growth of bacterial pathogens. Your response to the FDA-483 indicates that you intend the rice (b)(4) pH check and (b)(4) to provide adequate control for B. cereus growth and/or toxin formation through the noodle cooling and drying process. However, as noted above, you have not provided the results of the planned validation study referenced in your response.

c. (b)(4): Your “(b)(4)” process preventive control (b)(4) in your food safety plan lists temperature checks and pH checks as control mechanisms for pathogen growth [L. monocytogenes and C. botulinum in (b)(4). For temperature checks, you list a method of “Check Finished Product temperature ((b)(4)) ≤ (b)(4)” with a frequency of “(b)(4)”. Your finished RTE rice noodles are packaged before (b)(4) without the product temperature being monitored. Most foodborne bacteria and bacterial spores can survive refrigeration, and some relevant organisms can continue growing at or below 40°F. For pH checks you list a method of “Check Finished Product pH ≤ (b)(4)” with a frequency of “(b)(4)”. (b)(4) ≤ (b)(4) alone may not be adequate for Listeria control and your products were observed to be exposed to temperatures above 40°F for extended periods of time during finished product storage after packaging, which can allow for the growth of L. monocytogenes.

Additionally, FDA’s sampling results for your finished rice noodle products demonstrate that you do not consistently meet your critical limit of a pH (b)(4) in finished products (refer to Table 1 below). Also, you check the pH of (b)(4), which is not representative of the entire lot of approximately (b)(4) of rice noodles.

Your firm packages RTE rice noodles (various noodle sizes/types) in 1 lb. reduced oxygen packaging (ROP), in (b)(4) lb. (b)(4) film packaging, and in (b)(4) lb. packaging where (b)(4) is (b)(4) from the package and bags are (b)(4) closed (the latter two may create ROP conditions due to permeability of the packaging material). This creates anaerobic conditions that can allow for C. botulinum growth and toxin formation in the absence of adequate product pH and temperature controls. Your control method of a finished product pH of (b)(4) may provide adequate control for the hazard of C. botulinum at this processing step if properly implemented. However, FDA collected finished product samples from your E Cedar Street facility for pH and water activity analysis. The analysis found that your process did not consistently yield a finished product pH (b)(4) in accordance with the critical limit established by your firm. The results are summarized in the table below:

Table 1. FDA Sample Results- Finished Products Collected from E Cedar Street Facility

*Note: The water activity values were above 0.85 in the RTE rice noodle samples analyzed by FDA (water activity values ranged from 0.98 to 1.00).

Additionally, your temperature check control mechanism does not appear to provide adequate control for the finished product stage. For example, during the inspection our investigators observed the following:

• On January 28, 2026, our investigators measured temperatures between two bags from two different locations on a pallet of finished product Banh Pho Tuoi noodles, Lot (b)(4) ((b)(4) plastic ROP, (b)(4) per box), at 52°F and 53.5°F while stored in the cooler. The noodles had been cut and packaged on (b)(4), and visible condensate was observed inside the finished product packaging.
• On January 28, 2026, our investigators measured the temperature between two bags of finished product Pad Thai noodles, Lot (b)(4) ((b)(4) plastic ROP, (b)(4) per box), at 70.5°F while stored in the cooler. The noodles had been cut and packaged on (b)(4), and visible condensate was observed inside the finished product packaging.
• On February 12, 2026, cooked, in-process rice noodle sheets from Lot (b)(4), held (b)(4) Lines (b)(4), were observed stored at (b)(4) temperature. At 9:40 AM, our investigators measured the rice noodle sheet temperatures at 82°F, 77°F, and 81°F, respectively. At 3:32 PM, our investigators measured the rice noodle sheet temperatures at 79.5°F, 73°F, and 73°F, respectively. The rice noodle sheets remained at (b)(4) temperature (b)(4) until cut into individual noodles and packaged as Banh Pho Tuoi (10 lb.), Lot (b)(4), at approximately 5:30 AM and placed in the refrigerator at approximately 6:00 AM on February 13, 2026. At 9:13 AM on February 13, 2026, our investigators measured the temperature of a finished RTE 10 lb. ROP bag of Banh Pho Tuoi rice noodles in the refrigerator at 61°F.
• On February 23, 2026, our investigators measured the temperature between two bags of finished Banh Pho Tuoi noodles, Lot 04-23-A1 (10 lb. bags, (b)(4) and (b)(4) closed, (b)(4) bags per box), at 78.5°F at 9:10 AM. These products were placed in the cooler at approximately 9:05 AM. At 3:18 PM, our investigators measured the temperatures between the bags of finished rice noodles at 74.5°F. On February 24, 2026, at 11:10 AM, our investigators measured the temperature between the bags of finished rice noodles at 66.5°F. After 26 hours of refrigerator storage, the product had cooled by only 12°F.
• Packaged finished products from your firm’s S Parco Avenue facility are also stored at your E Cedar Street facility until distribution. On February 23, 2026, our investigators measured the temperature between two bags of finished Banh Pho Tuoi noodles, Lot 04-23-B1 ((b)(4) bags, (b)(4) and (b)(4) closed, (b)(4) bags per box), from the S Parco Avenue facility at 66.5°F at 9:10 AM. These products were placed in your E Cedar Street facility cooler at approximately 9:00 AM. At 3:18 PM, our investigators measured the temperatures between the bags of finished rice noodles at 66°F. On February 24, 2026, at 11:10 AM, our investigators measured the temperature between the bags of finished rice noodles at 62°F. After 26 hours of refrigerated storage, the finished product had cooled by only 4.5°F.

Your FDA-483 response included an updated process preventive control of testing the pH of (b)(4); however, we are unable to fully evaluate the response because it is unclear whether (b)(4) samples is representative of the entire batch of approximately (b)(4) of rice noodles. Moreover, a pH of (b)(4) alone may not be adequate for Listeria control. FDA recommends referencing Appendix 3, Table 3-A of our Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, which outlines the limiting conditions for L. monocytogenes growth. Additionally, your written response does not account for when the temperature of the RTE packaged rice noodles are not monitored during storage in the cooler before they are shipped, which can allow for pathogen growth and/or toxin formation in the finished product due to extended exposure to elevated temperatures over time. Your practice of not releasing product for shipment until it is (b)(4) does not provide adequate control for this hazard. As previously mentioned, most foodborne bacteria and bacterial spores can survive refrigeration, and some relevant organisms can continue growing at or below (b)(4).

We acknowledge receipt of certificates of destruction for your voluntary destruction of in-process and finished products as part of the corrective actions taken by your firm in response to these observations.

2. Your written sanitation preventive controls did not 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, to comply with 21 CFR 117.135(c)(3).

Your food safety plan listed the hazard of “Biological” and an associated sanitation preventive control of “Cleaning of equipment and utensils.” However, your cleaning practices for your food contact equipment after the (b)(4) step are not adequate to significantly minimize or prevent hazards given the infrequent nature of the cleaning. More specifically, during the inspection, our investigators observed that you use cut machines (b)(4), noodle trays (b)(4), and cut tables (b)(4) for daily production
runs, but the cleaning and sanitation is completed on a rotating basis, so equipment is cleaned and sanitized only (b)(4). This frequency does not ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards given that your RTE rice noodle sheets and RTE cut rice noodles are exposed to the environment after being (b)(4) and (b)(4) and (b)(4) handled by employees prior to being packaged, where they may be contaminated with environmental pathogens, such as L. monocytogenes and other pathogens due to poor sanitation and employee practices. We also note that the (b)(4) sheets used in direct contact with stacked RTE rice noodle sheets during drying/curing were not being cleaned and sanitized at all. These sheets were observed with discoloration, and some sheets had frayed edges as well.

Your response to the FDA-483 indicated you have updated your sanitation preventive controls by including personnel handwashing and an “EMP program” as new components. Your response also described a new equipment wipe down practice using (b)(4) in your Cutting/Packing Department and Noodle Receiving area at the (b)(4), and you noted that cleaning of electric fans and (b)(4) sheets are included in the wipe down activity for the Noodle Receiving area. We will evaluate the adequacy of your corrective actions during our next inspection.

S Parco Avenue Facility

3. You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR 117.126(a)(1). Your food safety plan must include the following:

1) The written hazard analysis, as required by § 117.130(a)(2);
2) The written preventive controls, as required by § 117.135(b);
3) The written supply‐chain program, as required by subpart G;
4) The written recall plan, as required by § 117.139(a);
5) The written procedures for monitoring the implementation of the preventive controls, as required by § 117.145(a);
6) The written corrective action procedures, as required by § 117.150(a)(1); and
7) The written verification procedures, as required by § 117.165(b).

Your facility manufactures refrigerated RTE rice noodles in ROP packaging. However, you did not have a food safety plan with any of the required elements for these products. For example, you did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for RTE rice noodles manufactured and packaged at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a). Also, you did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act [see 21 CFR 117.135(a)(1)]. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan [see 21 CFR 117.135(c)]. Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR 117.140).

For example, you did not identify growth and survival of bacterial pathogens, such as B. cereus, L. monocytogenes, and C. botulinum as known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control. Your in-process and finished ROP rice noodles are produced without time-temperature and/or (b)(4) and are likely to support the growth of bacterial pathogens and/or toxin formation. A knowledgeable person manufacturing/processing food in your circumstances would identify growth of bacterial pathogens as a hazard requiring a preventive control (e.g., process controls). Process controls include procedures, practices, and processes to ensure the control of parameters during operations. Where appropriate, process controls must also include the parameters associated with the control of the hazard and the minimum and/or maximum values needed to significantly minimize or prevent the hazards requiring a process control [see 21 CFR 117.135(c)(1)].

During the inspection, FDA investigators observed the following instances of time-temperature abuse of the RTE rice noodles:

• On February 11, 2026, our investigators measured the temperature of cooked in-process RTE Banh Pho Tuoi rice noodle sheets, Lot (b)(4), during the (b)(4) process on Lines (b)(4) and (b)(4) at 9:00 AM at 69°F and 66.5°F, respectively. The rice noodle sheets were stacked (b)(4) sheets in stacks approximately four feet high with a (b)(4) of each stack. At 10:14 AM the temperature of the rice noodle sheets was measured at 71.5°F and 64.5°F; at 12:19 PM the temperature was measured at 69°F and 65°F; and at 3:20 PM, was measured at 69°F and 66°F.
• The cut noodles are packed in 10 lb. bags with the (b)(4) removed and (b)(4) closed creating the potential for ROP conditions within the bag due to the permeability of the packaging material. The bags are packed in cases, the cases are palletized and wrapped in plastic wrap, and the pallets are transferred from the S Parco facility to the refrigerator at the E Cedar facility before being fully cooled. As noted in the E Cedar facility observations above, Lot 04-23-B1 of Banh Pho Tuoi noodles cooled by only 4.5°F over 26 hours (from 66.5°F to 62°F).

Further, FDA sample (#1317731) of refrigerated FRESH RICE STICK NOODLE BANH PHO TUOI (10 lbs., Lot (b)(4)) was collected and analyzed for pH and water activity. The finished product was found to have a pH range of 4.67 to 4.93 (original analysis) and 4.52 to 4.64 (check analysis). The water activity was found to be 1.0 (original analysis) and 0.99 (check analysis). These pH and water activity values may allow for bacterial pathogen growth and toxin formation.

Additionally, you did not identify recontamination with environmental pathogens, such as L. monocytogenes, as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. Your RTE rice noodles are exposed to the environment after being (b)(4) and (b)(4) dried and then (b)(4) by employees prior to packaging. The packaged noodles do not receive a lethal treatment or otherwise include another control that would significantly minimize the hazard of recontamination with environmental pathogens.

Contamination with environmental pathogens is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing 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)]. In addition, we note that verification activities must include, as appropriate, environmental monitoring if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control [see 21 CFR 117.165(a)(3)].

Your firm’s FDA-483 response dated March 17, 2026 provided a hazard analysis and preventive controls and an environmental monitoring program. We acknowledge that you intend to use pH, (b)(4), and temperature controls to ensure the safety of your finished RTE rice noodle products. However, your process preventive controls for the manufacturing of RTE rice noodles at your S Parco Avenue facility appear to be the same as those provided for your E Cedar Street facility. Accordingly, FDA has the same concerns regarding inadequate controls for bacterial pathogen growth and/or toxin formation as those discussed above for the E Cedar Street facility. We also note that the food safety plan, dated March 9, 2026 included in your FDA-483 response did not include a written recall plan as required.

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):

E Cedar Street Facility

1. Your plant was not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food and food-contact surfaces, as required by 21 CFR 117.20(b)(4). Specifically, on January 27, 2026, during the manufacturing of RTE rice noodle sheets (Lot (b)(4)), continuous (b)(4) around the (b)(4) vent hoods on (b)(4) Lines (b)(4) and (b)(4) were observed, with condensate collecting on the edge of the (b)(4) exhaust hoods directly over exposed noodle sheets. Condensate was observed to drip from the hood surface which is located at the (b)(4). The exterior surface of the (b)(4) hood on Line (b)(4) was observed with rust-like discoloration on the outer hood surface where condensate was forming.

Your response to the FDA-483 indicated that the (b)(4) vent hood was thoroughly cleaned and sanitized to prevent condensation and to remove rust. Your response is not adequate because it does not address how you would prevent condensate from forming and serving as a potential contaminant to food-contact surfaces and to your RTE rice noodle products (b)(4) the (b)(4) in the future.

S Parco Avenue Facility

2. You did not clean and sanitize your utensils and equipment in a manner that protects against contamination of food-contact surfaces, as required by 21 CFR 117.35(a). During cleaning and sanitation operations on January 29, 2026 in your S Parco facility, FDA investigators observed employees cleaning soiled equipment in a manner that caused overspray to contact food-contact surfaces of equipment that had already been cleaned.

Your response to the FDA-483 indicated that personnel were trained to avoid recontamination of cleaned equipment by avoiding splashing water. We will evaluate the adequacy of your corrective action during the next inspection of your facility.

3. You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas of your facility to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically,

a. On January 27, 2026, during the manufacturing of RTE Banh Pho Tuoi rice noodles (Lot (b)(4)), at least five apparent dead black winged insects were observed in (b)(4) and one bee-like insect was observed on the dispensing table adjacent to the (b)(4) bulk tote. Two live black winged insects were observed on a (b)(4) bag holding rice.

b. On February 5, 2026, during the manufacturing of RTE Banh Pho Tuoi rice noodles (Lot (b)(4)), two dead apparent cockroaches were observed in the facility. One insect was observed in the drain between the rice noodle (b)(4) lines, and one was observed between pallets of raw rice.

Your response to the FDA-483 addressed actions taken by your pest control company to treat for cockroaches and actions you have taken to prevent their entry into the facility. An employee training record covering the requirement for personnel to report pest sightings in the production facility was also provided and focused on cockroaches and mouse/rat activity. We note that the (b)(4) rice observed in contact with dead black winged insects was voluntarily discarded on January 27, 2026, following identification of this condition. We will evaluate the adequacy of your corrective actions during the next inspection.

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.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

We also offer the following comments:

• On February 3, 2026, FDA collected environmental swabs (FDA sample #1309377) from your E Cedar Street facility. Two (2) swabs collected from a (b)(4) tested positive for Listeria grayi. This (b)(4) was approximately (b)(4) area and approximately (b)(4).
• On February 10, 2026, FDA collected environmental swabs (FDA sample #1322596) from your S Parco Avenue facility. Two (2) swabs tested positive for Listeria innocua (including the food contact surface of the (b)(4) above the (b)(4) and the (b)(4) and two (2) locations were positive for Listeria grayi (b)(4) on the (b)(4).

These findings can be an indicator of inadequate sanitation and of conditions that support the growth of Listeria monocytogenes (a human pathogen) in your manufacturing facilities.

• We acknowledge the presence of cooking instructions on your product labeling and your work in establishing the adequacy of these instructions, however your rice noodles are a RTE food as it is reasonably foreseeable that your fully cooked rice noodles will be eaten without further processing that would significantly minimize biological hazards based on how consumers use your product.

Please notify FDA in writing, within fifteen (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 fifteen (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.

Please send your reply to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Valerie Potopsingh, Compliance Officer at valerie.potopsingh@fda.hhs.gov or by hardcopy to Food and Drug Administration, Attention: Valerie Potopsingh, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740. If you have any questions regarding this letter, you may contact Valerie Potopsingh, Compliance Officer, via email at valerie.potopsingh@fda.hhs.gov. Please include reference CMS #730689 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, JD MBA
Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program