FDA WARNING_LETTER - Tropical Bakery Wholesale - September 26, 2019

The FDA inspected a facility manufacturing ready-to-eat baked and frozen breads and pastries in Hialeah, Florida, from September 9-26, 2019. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (21 CFR Part 117), leading to the determination that the bakery products are adulterated.

Key violations include: 1. **Lack of Food Safety Plan:** The facility failed to prepare and implement a food safety plan, including hazard analysis, preventive controls, supply-chain program, recall plan, monitoring procedures, corrective action procedures, and verification procedures, as required by 21 CFR §117.126. 2. **Inadequate Hazard Analysis:** No hazard analysis was conducted for products, specifically failing to identify and evaluate undeclared allergens, biological hazards (e.g., *Clostridium botulinum*, *Salmonella*), environmental pathogens (*Listeria monocytogenes*), and mycotoxins. 3. **Pest Control Deficiencies:** Numerous live flies, a live bird, and live roaches were observed in processing and storage areas. Exterior doors lacked adequate screening, and clutter outside could harbor pests. 4. **Insufficient Cleaning and Sanitation:** Unclean utensils and equipment with heavy food residue were observed, leading to potential allergen cross-contact and microbial contamination. No written sanitation procedures were