FDA WARNING_LETTER - Golden Grains Bakery - June 20, 2024

The FDA inspected a ready-to-eat (RTE) food manufacturing facility in Charlotte, NC, from June 17-20, 2024, focusing on smoothie "Blender Bomb" operations. The inspection revealed serious violations of the CGMP & PC rule (21 CFR Part 117), which is prohibited by section 301(uu) of the Federal Food, Drug, and Cosmetic Act. A Form 483 was issued, and the company's July 15, 2024, response was reviewed.

Key violations include: 1. **Hazard Analysis Deficiency (Repeat Violation):** The facility failed to identify vegetative bacterial pathogens (e.g., Salmonella spp.) as a known or reasonably foreseeable hazard for coffee, hemp seeds, and chia seeds used in "Java Jolt Blender Bombs," which do not receive lethal treatment. This was a repeat violation from 2019 and 2021 inspections. Additionally, the supplier of coffee was not approved through their supplier approval program. The revised hazard analysis identified Salmonella, but the required annual onsite audit for high-risk ingredients was not confirmed. 2. **Failure to Implement Preventive Controls:** * **Metal Hazard:** The facility did not implement metal detection controls for "Blender Bomb" products, with records showing no metal detection since January 22, 2024. Intermittent, undocumented