FDA WARNING_LETTER - Pan-African Food Distributors Inc. - June 04, 2025

The FDA issued a Warning Letter to Pan-African Food Distributors Inc./East Africa Boutique LLC on November 13, 2025, following an inspection from May 6, 2025, to June 4, 2025. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117). Specifically, the facility failed to implement effective measures to exclude pests and protect food from contamination (21 CFR 117.35(c)). Investigators documented extensive evidence of rodent, insect, and animal activity throughout the warehouse, which stores dietary supplements and other foods. Observations included live and dead rodents directly contacting food products like corn meal and fumbwa leaves, numerous rodent excreta pellets on and around pallets of various food items, and gnaw holes in food packaging. Live and dead insects were also found in food and storage areas. Furthermore, a domestic cat roamed freely, with cat feces and urine observed on floors and pallets near food products. These insanitary conditions mean the company's food products are considered adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, rendering them potentially injurious to health. The Kentucky Department for Public Health issued a Cease Operation and Blanket Quarantine order, which remained active as of October 31, 2025. The FDA previously issued a consumer safety advisory for the firm's products. Pan-African Food Distributors must address these significant violations, provide evidence of corrective actions, and ensure sustained compliance to resolve these issues.