Brand Packaging Group, Inc.
FDA issued a warning letter to Brand Packaging Group, Inc. (Farmingdale, NY) following a March–April 2022 inspection that revealed significant CGMP violations in their dietary supplement manufacturing operations. The company failed to properly verify finished batch specifications, test incoming dietary ingredients for identity, reject components that failed established specifications, maintain valid laboratory controls for reference standards, and follow calibration procedures for testing instruments. FDA found these violations caused their dietary supplement products to be adulterated under 21 U.S.C. § 342(g)(1), and warned that failure to correct the issues could result in seizure or injunction.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action without further notice including, without limitation, seizure, and injunction.
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