Shah Distributors, Inc. – FDA Warning Letter, Mar 4, 2010

On July 15, 2010, the FDA issued a Warning Letter to Shah Distributors, Inc. following an inspection from February 8 to March 4, 2010. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for foods (21 CFR Part 110), rendering the firm's products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included: 1. **Pest Control:** Failure to exclude pests and protect against contamination (21 CFR 110.35(c)). Extensive rodent, bird, and insect activity was observed throughout the warehouse and repackaging area. This led to the destruction of approximately 43 tons of condemned food products by the Los Angeles County Department of Public Health (LACDPH) and 30 tons voluntarily destroyed by the firm. 2. **Equipment Maintenance:** Failure to maintain equipment in an acceptable condition through cleaning and sanitizing (21 CFR 110.80(b)(1)). The weigh/fill machine was not cleaned between different food products, with residue observed. 3. **Plant Construction/Design:** Deficiencies preventing contamination reduction (21 CFR 110.20(b)(2)). The repackaging area lacked physical barriers (no door, walls not extending to ceiling)