FDA WARNING_LETTER - Kamawi, Inc. - October 18, 2012

An FDA inspection of Kamawi, Inc., a manufacturer of ready-to-eat (RTE) flatbreads and other Afghan foods, conducted in October 2012, revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). Laboratory analysis confirmed the presence of bird excreta on direct product contact surfaces (conveyor belt) and rodent excreta pellets in the warehouse where finished product packaging is stored. These findings render the firm's foods adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions and potential filth contamination. Specific violations included failure to exclude pests and protect against contamination (21 CFR 110.35(c)), inadequate pest screening (21 CFR 110.20(b)(7)), infrequent cleaning of food-contact surfaces (21 CFR 110.35(d)), and employees not wearing hair nets (21 CFR 110.10(b)(6)). The letter noted that pest control and hair net deficiencies were cited in previous inspections, indicating persistent quality system issues. Kamawi, Inc. is required to take prompt corrective action and respond in writing within fifteen working days, detailing steps to prevent recurrence. Failure to comply may result in regulatory actions such as product seizure or injunction.