FDA WARNING_LETTER - McClure’s Lancaster Old Fashioned, LLC - October 03, 2023

The FDA inspected TNT Bakery (McClure’s Lancaster Old Fashioned, LLC) in Bowmansville, PA, from September 18 to October 3, 2023, finding serious violations of the CGMP and PC rule (21 CFR Part 117). The facility's ready-to-eat (RTE) sticky buns, pies, and cakes were deemed adulterated due to insanitary conditions, potentially leading to contamination.

Key violations include: 1. **Hazard Analysis Deficiencies (21 CFR § 117.130(a)(1))**: Failure to conduct a hazard analysis for RTE sticky buns, pies, and cakes, specifically regarding bacterial pathogens (e.g., Salmonella from eggs/wheat flour), environmental pathogens (e.g., Salmonella, L. monocytogenes) for post-cooking recontamination, and allergens (e.g., cross-contact on shared equipment). The facility had an Environmental Monitoring Program but hadn't implemented it, and it lacked details on timing, frequency, tests, and corrective actions (21 CFR § 117.165(b)(3)(iv), (v), (vii)). 2. **Equipment and Utensil Cleanability (21 CFR § 117.40(a)(1))**: Duct tape and gouges on PVC piping above exposed creme in the doughnut filler-hopper, making