FDA Sends Warning Letters

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction.
Ee Hui Food Manufacture PTE Ltd. — SingaporeThe Food and Drug Administration sent a warning letter dated Nov. 22, 2019, to the president of Ee Hui Food Manufacture PTE Ltd., Cheng Hwee Ng.
During an inspection at Ee Hui Food Manufacture’s seafood processing facility on June 24 and 25, FDA investigators found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). The warning letter says that, “failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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).”
U.S. Dairy Unlimited LLC — Miami, FLThe Food and Drug Administration sent a warning letter dated Nov. 19, 2019, to Ury Zyman, owner of U.S. Dairy Unlimited LLC.
During an inspection at U.S. Dairy Unlimited LLC, a ready-to-eat (RTE) cheese manufacturing facility, from June 24 to July 3, FDA investigators found 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). The warning letter says that, “based on FDA’s inspectional findings, we determined that cheese 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 U.S.C. § 342(a)(4)], in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls 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)).”

Source: Warning letters sent to two seafood processing facilities and cheese manufacturing facility | Food Safety News