Brand Packaging Group, Inc.

Warning LetterOpen

Lawrence S. Sayage President Brand Packaging Group, Inc. 85 Price Parkway Farmingdale , NY 11735-1305 United StatesFEI 3008140401Issued Mar 17, 2023Division of Human and Animal Food Operations East I

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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 3008140401.

Violations5

Issue DateMar 17, 2023

Product TypeDietary Supplements

StatusOpen

Letter Details

Firm: Brand Packaging Group, Inc.
Location: Lawrence S. Sayage President Brand Packaging Group, Inc. 85 Price Parkway Farmingdale , NY 11735-1305 United States
FEI Number: 3008140401
Country: United States
Issue Date: March 17, 2023
Issuing Office: Division of Human and Animal Food Operations East I
Product Type: Dietary Supplements
Status: Open

Summary

Brand Packaging Group, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing and packaging of dietary supplements at its Farmingdale, NY facilities during an inspection conducted in March-April 2022. The company failed to verify that finished dietary supplement batches met required product specifications for identity, purity, strength, and composition through actual analytical testing, instead relying on certificates of analysis based on production input rather than testing of the finished products themselves. These violations rendered the company's dietary supplement products adulterated under federal law, as they were prepared and held under conditions that did not meet CGMP requirements.

Brand Packaging Group, Inc. FDA Warning Letter, March 17, 2023