FDA WARNING_LETTER - Staples, Incorporated - November 03, 2011

On March 7, 2012, the FDA issued a Warning Letter to Staples, Incorporated, following an inspection of their Stockton, CA facility from October 20 to November 3, 2011. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for foods (21 CFR Part 110), causing food products to be adulterated under Sections 402(a)(4) and 402(a)(3) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Pest Control (21 CFR 110.35(c))**: Extensive rodent activity was observed, including 3-20 rodent excreta pellets (REPs) on or near multiple food products (candies, crackers, creamers, pistachios, ramen noodles, bottled water) throughout the warehouse. Twenty-three out of 39 rodent traps contained dead rodents, and a 4"x5" hole in a wall contained a dead rodent. REPs were found in a water cooler dispenser and on top of boxes. Rodent-gnawed holes were seen on at least 10 different food products, and lab analysis confirmed gnawed peanut butter and cheese sandwich crackers. 2. **Protection Against Pests (21 CFR 110.20(b)(7))**: Twenty-four exterior doors had gaps greater