FDA 483 - Pharmaceutical Specialties, Inc. - May 03, 2019

An FDA inspection of Pharmaceutical Specialties, Inc. in Rochester, MN, a manufacturer of OTC drug products, revealed significant deficiencies in their quality control systems. Observations included a lack of written procedures and process validation for drug product manufacturing, as well as inadequate cleaning validation for equipment. Furthermore, the firm's Quality Unit failed to reject a subpotent batch of Vanicream™ Sunscreen, leading to its release and distribution.