483
Pharmaceutical Specialties, Inc.FDA 483 - Pharmaceutical Specialties, Inc. - May 03, 2019
Record Details
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.
- Person
Open in Dashboard
ID · 4eea6d7a-e4d5-4e11-845f-3031e5075c16