FDA 483 - Dr. J Skinclinic, Inc - March 17, 2022
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 Dr. J Skinclinic, Inc. in Cerritos, CA, revealed significant deficiencies in their manufacturing processes for OTC drug products. The firm failed to perform identity testing for active pharmaceutical ingredients, did not maintain or make readily available critical production and distribution records, and lacked stability data to establish expiration dates. Additionally, the company's quality unit did not conduct required annual product quality reviews for several years.
ID · bcc9abe2-bc3b-47b9-aa22-ad3be5cb4de3