Knickerbocker 365 Inc. – FDA Warning Letter, May 31, 2024

The FDA inspected a ready-to-eat (RTE) breads, rolls, and buns manufacturing facility at 26040 Pinehurst Dr., Madison Heights, MI, from April 29 to May 31, 2024. 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), rendering the products adulterated under section 402(a)(4) of the Federal Food Drug and Cosmetic Act.

Key violations include: 1. **Hazard Analysis Deficiencies:** The firm's hazard analysis for RTE breads, rolls, and buns did not identify recontamination with environmental pathogens (e.g., Salmonella) at post-baking steps (Cooling, De-panning, Slicing, Packaging) as a hazard requiring a preventive control. Sanitation procedures for post-baking equipment lacked details on sanitizer concentration and cleaning of utensils/clean-out-of-place (COP) equipment. The environmental testing document was unclear on pathogen sampling frequency and analytical methods, and the firm was not following its own environmental monitoring procedure, failing to send samples to the specified lab for analysis. 2. **Supply Chain Program Deficiencies:** The firm lacked a written risk-based supply chain program for ingredients (wheat flour, whey, egg, walnut) identified as having pathogen hazards requiring supply-chain-applied controls