FDA WARNING_LETTER - Pollman's Bake Shops, Inc. - June 13, 2019

The FDA inspected a bakery and central kitchen facility at 750 South Broad Street, Mobile, Alabama, from June 3-5 and 13, 2019. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117), leading to the determination that food manufactured at the facility is adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **Hazard Analysis and Risk-Based Preventive Controls (Subpart C):** * Failure to conduct a hazard analysis for any products, specifically not identifying undeclared allergens, environmental pathogens (Listeria monocytogenes, Salmonella), vegetative pathogens (pathogenic E. coli, Salmonella), mycotoxins, or physical hazards (metal) as requiring preventive controls. * Failure to determine if a supply-chain-applied control was needed for raw materials. * Failure to identify and implement preventive controls (process, food allergen, sanitation, supply-chain, recall plan). * Failure to prepare and implement a written food safety plan, including required components like hazard analysis, preventive controls, supply-chain program, recall plan, monitoring, corrective action, and verification procedures.

2. **Current Good Manufacturing Practice (Subpart B):**