Knickerbocker 365 Inc.

Warning LetterOpen

Sandra T. Sokana President/Owner Knickerbocker 365 Inc. 26040 Pinehurst Dr. Madison Heights , MI 48071 United States (b)(6)FEI 3003613292Issued Sep 30, 2024Office of Human & Animal Food Operations East 6

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3003613292.

Violations8

Issue DateSep 30, 2024

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: Knickerbocker 365 Inc.
Location: Sandra T. Sokana President/Owner Knickerbocker 365 Inc. 26040 Pinehurst Dr. Madison Heights , MI 48071 United States (b)(6)
FEI Number: 3003613292
Country: United States
Issue Date: September 30, 2024
Issuing Office: Office of Human & Animal Food Operations East 6
Product Type: Food & Beverages
Status: Open

Summary

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.

Knickerbocker 365 Inc. FDA Warning Letter, September 30, 2024