What happened
Original notice title
Pan-African Food Distributors Inc./East Africa Boutique LLC MARCS-CMS 717171, November 13, 2025
From the archived source record
During our inspection of your facility, the FDA investigators found 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). Based on FDA’s inspectional findings, we determined that your food products 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, it is a prohibited act under section 301(k) of the Act [21 U.S.C. § 331(k)] to do any act with respect to a food or cosmetics, if such act is done while the products are held for sale after shipment in interstate commerce and results in the products being adulterated. On May 27, 2025, you initiated a voluntary recall of two food products that had been stored and distributed from your facility. On June 3, 2025, FDA updated the consumer safety advisory due to concerns for all food and cosmetic products held and distributed by your firm. Following review of the inspectional findings and your response, FDA is issuing this letter to communicate our concerns and provide detailed information regarding the findings documented at your facility. Your significant violations were as follows: Current Good Manufacturing Practice (21 CFR Part 117, Subpart B) 1. You did not take effective measures to exclude pests from your holding areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 117.35(c). You did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required per 21 CFR 117.35(a).
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 159f2822f7c7
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →