FDA 483 - Premier Brands of America Inc. - November 21, 2025

An FDA inspection of Premier Brands of America Inc in Hudson, NY, an OTC repacker/relabeler, revealed significant deficiencies in drug product storage conditions. The firm failed to conduct temperature mapping studies for warehouse areas storing raw materials and finished goods, and lacked adequate temperature monitoring controls. These issues raise concerns about the identity, strength, quality, and purity of OTC drug products requiring specific storage conditions.