Pet Center, Inc. – FDA Warning Letter, Oct 8, 2021

The FDA issued a Warning Letter to a pet treat manufacturer following inspections from September 21 to October 8, 2021, and a prior inspection from June 21 to July 13, 2021. The inspections revealed significant violations of FDA's Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls requirements for animal food (21 CFR Part 507), rendering products like Bully Sticks and SuperChews adulterated.

Key violations include: 1. **Failure to implement a written food safety plan (21 CFR 507.31(a))**: The firm admitted no hazard analysis or preventive controls were identified, a repeat observation. 2. **Inadequate precautions against contamination (21 CFR 507.25(a)(5))**: An employee stepped into a cooker with soiled boots, and high-pressure cleaning splashed raw material onto cooked product. 3. **Improper cleaning and maintenance of equipment (21 CFR 507.19(b))**: A shovel used for cooked product was stored on the floor and not cleaned/sanitized before use. 4. **Failure to exclude pests (21 CFR 507.19(e))**: Animal feces, flies, and gnawed rodenticide were found in processing areas, and exposed product was stored outside, a repeat observation.