FDA
August 08, 2022
RE: CMS #: 630545
WARNING LETTER
Dear Mr. Anchirayco:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) dips, soups, salad bases, burritos, entrée style meals, and seafood products manufacturing facility located at 2700 Westinghouse Blvd, Charlotte, NC, 28273-0113, on February 7-11, 15, and 23, 2022. During our inspection, we collected environmental samples (swabs) from various areas in your facility. FDA laboratory analyses found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA 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) and Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).
Based on FDA’s inspectional findings and the analytical results for the environmental swabs, we have determined that the ready-to-eat 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 rendered injurious to health. Furthermore, in accordance with 21 CFR 123.6(g), 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 Act, 21 U.S.C. § 342(a)(4). 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)). You may find the Act, further information about the CGMP & PC rule, and the seafood HACCP regulation through links in FDA’s home page at http://www.fda.gov.External Link Disclaimer
At the conclusion of the inspection, the FDA investigators issued your facility a Form 483 (FDA-483), Inspectional Observations. You provided responses to the inspection and sample findings on March 16, April 16, May 13, and June 15, 2022, describing corrective actions taken by your firm. Based on our review of the inspectional findings and the responses that your firm provided, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.
