FDA "observed multiple instances of time-temperature abuse at steps of the (b)(4) process. These observations, and an analysis of FDA samples collected during the inspection, demonstrate that the company did not have processes in place to monitor the (b)(4) of rice or (b)(4) of finished products after (b)(4) to prevent microbial pathogen growth and/or toxin formation (such as Bacillus cereus, Clostridium perfringens, and Clostridium botulinum) when manufacturing refrigerated RTE Vietnamese rice noodles and refrigerated not RTE Vietnamese rice cakes, including reduced oxygen packaged (ROP) noodles and rice cakes"
FDA observed that the company did "not monitor, nor have controls in place for, the (b)(4) finished RTE rice noodle and not RTE rice cake products after (b)(4)."
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/minh-phung-inc-723409-04222026
Minh Phung, Inc.
MARCS-CMS 723409 — April 22, 2026
Recipient:
Ms. Chuyen T. Huynh
President
Minh Phung, Inc.
15216 Weststate St.
Westminster, CA 92683-6531
United States
dinh.emily@gmail.com
Issuing Office:
Human Foods Program
United States
April 22, 2026
WARNING LETTER
Re: CMS # 723409
Dear Ms. Huynh:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility located at 15216 Weststate St., Westminster, CA 92683, from October 2 through October 17, 2025. Your firm manufactures ready-to-eat (RTE) rice noodles and not RTE rice cakes. During our inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117, Subparts B and D). In addition, during the inspection, FDA collected two samples from your products and analyzed them for water activity and pH.
Based on FDA’s inspectional and analytical findings, we have determined that the rice noodle and rice cake products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code, (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. You may find the Act and further information about the CGMP & PC rule through links on FDA’s homepage at www.fda.gov.
At the conclusion of the inspection, the FDA investigator issued a Form FDA 483 (FDA-483), Inspectional Observations, listing deviations found at your facility. We received your written response to the FDA-483 on November 7, 2025, describing your planned and implemented corrective actions. Based on our review of the inspectional and analytical findings and your response, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility. We discuss your response below.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)
1. You did not conduct all food manufacturing, processing, packaging, and holding under conditions and controls necessary to minimize the potential for the growth or survival of microorganisms, contamination of food, and deterioration of food, as required by 21 CFR 117.80(c)(2).
Specifically, during the inspection of your facility, our investigator observed multiple instances of time-temperature abuse at steps of the (b)(4) process. These observations, and an analysis of FDA samples collected during the inspection, demonstrate that you do not have processes in place to monitor the (b)(4) of rice or (b)(4) of finished products after (b)(4) to prevent microbial pathogen growth and/or toxin formation (such as Bacillus cereus, Clostridium perfringens, and Clostridium botulinum) when you manufacture refrigerated RTE Vietnamese rice noodles and refrigerated not RTE Vietnamese rice cakes, including reduced oxygen packaged (ROP) noodles and rice cakes. Further, you told the investigator (b)(4). This is additional time that your products are exposed to uncontrolled temperatures.
a. (b)(4) of rice during preparation of rice cakes: On October 6, 2025, rice started (b)(4) AM. Our investigator measured the (b)(4) rice temperature at (b)(4)°F at (b)(4) AM and at (b)(4)°F at (b)(4) AM. The rice (b)(4) for approximately (b)(4) hours and (b)(4) minutes at temperatures ranging from (b)(4)°F to (b)(4)°F. The (b)(4) rice was (b)(4) into rice milk from (b)(4) AM until approximately (b)(4) PM and then placed in the refrigerator. Our investigator measured the (b)(4) rice milk temperature at (b)(4)°F at (b)(4) AM and at (b)(4)°F at (b)(4) PM (approximately (b)(4) hours after the start of production). The rice milk was stored in the refrigerator overnight and then used to produce Lot (b)(4) of not RTE Banh Bot Chien/Pure Rice Cake, Banh Bot Khoai Mon/Taro Rice Cake, and Banh Bot Cu Cai/Daikon Rice Cake on October 7, 2025.
b. (b)(4): Your finished products are allowed to cool at ambient temperature and some are packaged before they are fully cooled and refrigerated. During the inspection, our investigator observed that you do not monitor, nor do you have controls in place for, the (b)(4) of your finished RTE rice noodle and not RTE rice cake products after (b)(4). For example:
i. On October 6, 2025, our investigator measured the temperature of cooked RTE Banh Canh Bot Gao/Vietnamese Rice Tapioca Noodles after (b)(4) in a water bath at (b)(4)°F at (b)(4) AM. Product was then vacuum packed in ROP and placed in the refrigerator. During packaging, the rice noodles were stored at ambient temperature until all noodles were packed in ROP and were not placed into the refrigerator until 12:00 PM. Our investigator measured the temperature of the packed case in the refrigerator at 72°F at 2:06 PM.
ii. On October 6, 2025, our investigator measured the temperature of cooked RTE Bun Tuoi/Vermicelli noodles at the end of the (b)(4) process at (b)(4)°F at (b)(4) AM. (b)(4) noodles were hand packed onto plastic trays at ambient temperature directly after (b)(4) and (b)(4) took approximately (b)(4) minutes. Product was then placed in the refrigerator. Our investigator measured the internal product temperature of the (b)(4) noodles in the refrigerator at (b)(4)°F at (b)(4) AM and at (b)(4)°F at (b)(4) AM.
iii. On October 6, 2025, our investigator measured the temperature of cooked not RTE Banh Bot Chien/Pure Rice Cake and Banh Bot Khoai Mon/Taro Rice Cake Lot (b)(4) while they were (b)(4) at ambient temperature. The investigator recorded a temperature of (b)(4)°F at (b)(4) AM after steaming had been completed around (b)(4) AM. At approximately (b)(4) PM, the rice cakes were moved to the refrigerator and the rice cake temperature was measured at (b)(4)°F at (b)(4) PM and at (b)(4)°F at (b)(4) PM. An FDA sample of ROP refrigerated Banh Bot Chien/ Pure Rice Cake (Lot (b)(4)) was analyzed and found to have a pH range of (b)(4) (original analysis) and (b)(4) (check analysis). Water activity was found to be (b)(4) (original and check analyses).
iv. On October 7, 2025, our investigator measured the temperatures of cooked RTE Banh Canh Bot Gao Loc/Vietnamese Rice Tapioca Noodles after (b)(4). The investigator recorded a temperature of (b)(4)°F at (b)(4) AM. The packaging of rice noodles in ROP at ambient temperature started at approximately (b)(4) AM. Our investigator measured the rice noodle temperature at (b)(4)°F at (b)(4) AM and at (b)(4)°F at (b)(4) PM. The ROP rice noodles were stored at ambient temperatures until all noodles were packaged and the cases of finished product were placed in the refrigerator to cool at (b)(4) PM. Our investigator measured the temperature of the packed case in the refrigerator at (b)(4)°F at (b)(4) PM and at (b)(4)°F at (b)(4) PM. An FDA sample of ROP refrigerated Banh Canh Bot Gao Loc/Vietnamese Rice Tapioca Noodles was analyzed and found to have a pH range of (b)(4) (original analysis) and (b)(4) (check analysis). Water activity was found to be (b)(4) (original and check analyses).
The pH and water activity values for your finished products and the observed time-temperature abuse of these products during production and storage may allow for microbial pathogen growth and/or toxin formation which can present significant food safety hazards. FDA recommends referencing our Hazard Analysis and Risk-Based Preventive Controls for Human Foods: Draft Guidance for Industry Appendix 3, Table 3-B that provides the maximum cumulative exposure times at specific temperatures for the potential hazards for growth and toxin formation of Bacillus cereus, Clostridium perfringens, and Clostridium botulinum to consider when evaluating your production process. Further, your use of ROP for finished products is concerning based on the time-temperature abuse observed during our inspection. ROP should not be used unless appropriate barriers to Clostridium botulinum growth and toxin formation are implemented. FDA advises utilizing Chapter 4: Preventive Controls in the Hazard Analysis and Risk-Based Preventive Controls for Human Foods: Draft Guidance for Industry to identify suitable control measures for these hazards. Additionally, Appendix 3, Table 3-A provides limiting conditions for pathogen growth that can be applied to control relevant hazards through product formulation.
Your response to the FDA-483 dated November 7, 2025, did not provide any corrective actions regarding how you would address your (b)(4) processes to protect products from time-temperature abuse. Rather, you indicated that you would need more time to address these issues, would seek help from a qualified professional, and would “get back [to FDA] as soon as possible.” However, to date, you have not provided additional information to the Agency regarding these issues.
Modified Requirements for Qualified Facilities (21 CFR Part 117, Subpart D)
2. Your facility meets the definition of a qualified facility1 under the CGMP & PC rule and therefore is subject to the modified requirements in 21 CFR 117.201. A qualified facility is required to submit an attestation to FDA that the facility is a qualified facility (21 CFR 117.201(a)(1)). In addition, a qualified facility is required by 21 CFR 117.201(a)(2) to submit one of the two following attestations to FDA:
An attestation that you have identified the potential hazards associated with the food being produced, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are effective; or
An attestation that the facility is in compliance with State, local, county, tribal, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries, including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight.
To date, you have not submitted such an attestation.
The violations cited in this letter are not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the cause 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 do so may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
In addition to the violations described above, we offer the following comment:
The product labels on your not RTE Banh Bot Chien, Banh Bot Khoai Mon, and Banh Bot Cu Cai rice cake products do not include (b)(4) instructions. The lack of (b)(4) instructions on these product labels could render the labels misleading if these not RTE products could reasonably be interpreted as RTE products. Under section 403(a)(1) of the FD&C Act [21 U.S.C. § 343(a)(1)], a food is misbranded if its labeling is misleading in any particular.
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 #723409 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
S/
Thomas Kuntz
Acting Deputy Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
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