The United States Food and Drug Administration (FDA) inspected your refrigerated, frozen, and ambient food product warehouse located at 14100 Auto Park Way Ste. I, Houston, TX on August 7 through 15, 2023. During our inspection, 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) in Title 21, Code of Regulations, Part 117 (21 CFR part 117). At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing deviations found at your firm. In addition, during the inspection, FDA collected filth samples from various areas within your warehouse facility, and the analytical results revealed rodent filth present throughout your facility.
Based on FDA’s inspectional findings, we have determined that the food products warehoused in your facility are adulterated within the meaning of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(3)] because they consist in whole or in part of any filthy, putrid, or decomposed substance, or are otherwise unfit for food, and section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] because 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 FDA regulations through links in FDA’s Internet home page at http://www.fda.gov.
