Premier Brands Of America Inc. – FDA EIR, May 16, 2022

An FDA inspection of Premier Brands Of America Inc., a drug labeler/relabeler and manufacturer in Orangeburg, NY, was conducted from May 9-16, 2022. This comprehensive surveillance inspection, aligned with Compliance Program 7356.002 for Drug Manufacturing and 7356.002B for Drug Repackagers and Relabelers, identified six significant issues. Violations included a failure to thoroughly investigate unexplained discrepancies and out-of-specification stability results in a timely manner, and the absence of health hazard evaluations. The firm also accepted supplier Certificates of Analysis without validating their reliability. Deficiencies were noted in manufacturing process validation, which lacked scientific justification to assure consistent drug product quality. Furthermore, cleaning procedures for equipment were not adequately validated, and drug products were not stored under appropriate temperature conditions due to a lack of formal temperature mapping studies. Lastly, Annual Product Reviews were not conducted for individual product lines and were not completed promptly. Premier Brands of America Inc. acknowledged these observations and committed to providing a written response and implementing necessary corrections within 15 business days.