Monthly Archives: January 2024

FDA

The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, located at 2001 Broussard St., Tyler TX 75701 on April 17-21, 2023. Your firm manufactures and repackages, among other food products, ready-to-eat (RTE) seasoning blends. During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, FDA issued a Form FDA 483 (FDA- 483), Inspectional Observations, listing the deviations found at your firm. Based on FDA’s inspectional findings, we have determined that the ready-to-eat (RTE) seasoning 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 become 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)]. Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause  your seasoning blends and Dr. Botanical Health products to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343).