USA – FDA – Warning Letter – Gold Coast Distributors Inc. dba Shah Distributors

FDA

The United States Food and Drug Administration (FDA) inspected your ambient and frozen warehouse and re-packing facility, located at 2325 W. Charter Way, Stockton, CA 95206, from May 09-27, 2022. During our inspection of your facility, the FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, the FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations, listing the 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, insect, or cat filth present all throughout your facility.