Brands International Corporation

Warning LetterOpen

Mr. David Kahan Managing Partner Brands International Corporation 101 Chase Avenue Suite 204 Lakewood , NJ 08701 United StatesFEI 3007389902Issued Dec 17, 2024Center for Drug Evaluation and Research (CDER)

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Violations9

Issue DateDec 17, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Brands International Corporation
Location: Mr. David Kahan Managing Partner Brands International Corporation 101 Chase Avenue Suite 204 Lakewood , NJ 08701 United States
FEI Number: 3007389902
Country: United States
Issue Date: December 17, 2024
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Brands International Corporation, a pharmaceutical drug manufacturer in Canada, was cited for Current Good Manufacturing Practice (CGMP) violations and adulteration under federal law. During an FDA inspection in June 2024, investigators documented that the firm limited and delayed the inspection through hostile management behavior, including shoving and shouting at inspectors, and refusing to open drug stability chambers. The company's non-conformance with required manufacturing, processing, packing, and holding controls rendered their drug products adulterated, constituting violations of both sections 501(a)(2)(B) and 501(j) of the Federal Food, Drug, and Cosmetic Act.

Brands International Corporation FDA Warning Letter, December 17, 2024