Sina Bakery, Inc. – FDA Warning Letter, Dec 17, 2014

On March 3, 2015, the FDA issued a Warning Letter to Sina Bakery, Inc., following an inspection from December 15-17, 2014. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering the firm's food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Violations included: 1. **Pest Exclusion Failure (21 CFR 110.35(c)):** Approximately 25 live insects, appearing to be cockroaches, were found in the walk-in proofer box, crawling on walls, ceiling, and equipment. About 60 piles of apparent feline fecal matter were observed in a walk-in cooler used for storing operational and decommissioned equipment. The main entrance roll-up door lacked pest exclusion measures and was open throughout the inspection. 2. **Unsanitary Toilet Facility (21 CFR 110.37(d)(1)):** The toilet facility lacked toilet paper, hand soap, hand sanitizer, and an effective hand-drying measure. 3. **Inadequate Hand Washing Facility (21 CFR 110.37(e)(2)):** The hand washing facility near processing benches lacked soap and a suitable hand-drying device.

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