FDA 483 - Pharmaceutical Specialties, Inc. - May 03, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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
ID · 4eea6d7a-e4d5-4e11-845f-3031e5075c16