FDA WARNING_LETTER - Minh Phung, Inc. - October 17, 2025

Minh Phung, Inc., a food manufacturer based in Westminster, California, received a formal warning letter from the FDA following inspections conducted between October 2 and October 17, 2025. The agency identified significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) regarding the production of ready-to-eat rice noodles and rice cakes. The primary violations involve the firm"s failure to maintain adequate time-temperature controls during critical production phases, such as rice soaking and finished product cooling. Investigators observed products stored at ambient temperatures for extended periods, creating conditions conducive to the growth of pathogens like Bacillus cereus and Clostridium botulinum. Furthermore, the firm utilized reduced oxygen packaging without implementing sufficient barriers to prevent toxin formation, and analytical testing confirmed pH and water activity levels that exacerbate these safety risks. The FDA also noted that the company failed to submit required attestations for operating as a qualified facility and neglected to include necessary cooking instructions on labels for non-ready-to-eat products. Under the Federal Food, Drug, and Cosmetic Act, these products are deemed adulterated due to being prepared under insanitary conditions. Minh Phung, Inc. is required to provide a written response within 15 working days detailing the specific corrective steps taken to address these deficiencies and prevent their recurrence. Failure to comply may lead to regulatory actions, including product seizure or facility registration suspension.