Sweet Ann Cake, Inc. – FDA Warning Letter, Jul 19, 2019

The FDA inspected Carr #867 Km 7.8 Lote #3 Calle Bruno Cruz, Zona Industrial Toa Baja, Puerto Rico, from June 24 to July 19, 2019, finding serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). This resulted in the facility's Ready-to-Eat (RTE) bakery products being deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Significant violations include: 1. **Hazard Analysis (21 CFR §117.130(a)):** Failure to conduct a hazard analysis for products, specifically not identifying allergen cross-contact, pathogens (Clostridium botulinum, E. coli, Salmonella, Staphylococcus aureus), environmental pathogens (Listeria monocytogenes, Salmonella) for RTE foods exposed to the environment, and mycotoxins as known or reasonably foreseeable hazards. 2. **Food Safety Plan (21 CFR §117.126(a)(1)):** Failure to prepare and implement a food safety plan. 3. **Preventive Controls (21 CFR §117.135(a)):** Failure to identify and implement preventive controls (process, allergen, supply-chain) and establish written procedures