FDA 483 - Premier Brands Of America Inc. - May 16, 2022

An FDA inspection of Premier Brands of America Inc. in Orangeburg, NY, revealed significant deficiencies in quality control and manufacturing processes for drug products. The firm failed to thoroughly investigate out-of-specification results and complete investigations within prescribed timeframes. Other issues included inadequate supplier qualification, lack of validated manufacturing processes and cleaning procedures, improper temperature monitoring, and deficient annual product reviews.