FDA 483 - Zhejiang Dingtai Pharmaceutical Co., Ltd - February 28, 2025
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 Zhejiang Dingtai Pharmaceutical Co., Ltd, a manufacturer of OTC drug products, revealed three significant observations. The firm was cited for inadequate laboratory controls, specifically regarding microbiological media preparation and testing, and for insufficient control procedures for manufacturing processes. Additionally, the inspection found a lack of detailed written procedures for the sampling, testing, approval, and rejection of components.
ID · c42b49e1-6f7e-47c3-96a1-45ba7b7f9267