Minh Phung, Inc. — FDA Warning Letter, 2026-04-22: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
TL;DR
FDA issued a Warning Letter to Minh Phung, Inc. on 2026-04-22 citing: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/minh-phung-inc-723409-04222026
Argus analysis
Minh Phung, Inc. (MARCS-CMS 723409) received an FDA Warning Letter dated April 22, 2026 from the Human Foods Program. The letter cites: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on May 12, 2026.
CGMP citations typically reference 21 CFR Part 211 (finished pharmaceuticals) or Part 111 (dietary supplements), covering subjects such as identity testing of incoming components, validated cleaning procedures, batch-failure investigations, and stability program design. Repeat or systemic findings are what typically drive FDA toward import alert or consent decree escalation.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same CGMP (Current Good Manufacturing Practice) category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Minh Phung, Inc. MARCS-CMS 723409 — April 22, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA ELECTRONIC DELIVERY Product: Food & Beverages Recipient: Recipient Name Ms. Chuyen T. Huynh Recipient Title 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 a nd 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 r…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- Is the FDA warning letter to Minh Phung, Inc. publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/minh-phung-inc-723409-04222026.
- What does a "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
- What is the regulatory background for a CGMP — Current Good Manufacturing Practice warning letter?
- CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Minh Phung, Inc. — FDA Warning Letter, 2026-04-22: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-minh-phung-inc-2026-04-22-cgmp
"Minh Phung, Inc. — FDA Warning Letter, 2026-04-22: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-minh-phung-inc-2026-04-22-cgmp.
Argus HQ Research. "Minh Phung, Inc. — FDA Warning Letter, 2026-04-22: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-minh-phung-inc-2026-04-22-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_minh_phung_inc_2026_04_22_cgmp_2026,
title = {Minh Phung, Inc. — FDA Warning Letter, 2026-04-22: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-minh-phung-inc-2026-04-22-cgmp},
note = {Accessed: July 13, 2026}
}