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Knickerbocker 365 Inc., a manufacturer of ready-to-eat breads, rolls, and buns in Michigan, was cited for serious violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls regulations during an FDA inspection conducted from April through May 2024. The company's products were determined to be adulterated because they were prepared, packed, or held under insanitary conditions that could have resulted in contamination with filth or rendered them injurious to health. The facility failed to comply with multiple preventive controls provisions required under 21 CFR Part 117, including requirements in Subparts A, C, D, E, F, and G.