FDA WARNING_LETTER - Bharat Bazar, Inc. - April 22, 2015

On July 13, 2015, the FDA issued a Warning Letter to Bharat Bazaar, Inc., following an inspection of their Fremont, CA warehouse and repacking facility from April 14-22, 2015. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering their food products, including flour, moong beans, and cumin seeds, adulterated under 21 USC 342(a)(4) due to insanitary conditions.

Key violations included: 1. **Pest Exclusion (21 CFR 110.35(c)):** Extensive rodent excreta pellets (REPs) and gnaw holes were found in the packaging area (499 REPs on/in flour bags), repacking area floors (87 REPs), office bathroom (37 REPs), and packaged area floors (293 REPs, 42 REPs under pallets/bins), and under a work table (5 REPs). While 35 bags of flour were destroyed, the firm's corrective actions for pest control require verification. 2. **Equipment Cleaning/Sanitizing (21 CFR 110.35(a)):** A vacuum cleaner used for cleaning the flour repacking machine was also used to clean REPs from floors and shelves, without subsequent cleaning/sanitizing of