ADAO, Inc. – FDA Warning Letter, Dec 22, 2010

The FDA inspected ADAO, Inc.'s food manufacturing facility from December 15-22, 2010, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, products like Double Cheese Stack, Mediterranean, Grilled Chicken & Provolone Cheese, and Mandarin Orange were found to be misbranded under Section 403 of the Act and 21 CFR Part 101.

Key violations include: 1. **Pest Infestation (21 CFR 110.35(c)):** Rodent excreta pellets were found in multiple areas, including food storage, utensil containers, and production rooms. 2. **Inadequate Pest Exclusion (21 CFR 110.20(b)(7)):** Significant gaps were observed in loading dock doors and an exterior kitchen door, and a hole in the kitchen wall, allowing pest entry. The firm's response was inadequate due to a lack of timeframe for repairs. 3. **Improper Storage/Waste Management (21 CFR 110.20(a)(1)):** Clutter, unused equipment, and debris were stored in the garage and along the exterior wall, creating pest harborage. The firm