FDA 483 - Chunghwa Chemical Synthesis & Biotech Co., Ltd - November 14, 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 Chunghwa Chemical Synthesis & Biotech Co., Ltd. in New Taipei City, Taiwan, an API manufacturer, revealed significant deficiencies. Observations included inadequate monitoring of the water system's microbial counts, a lack of review for electronic raw data in the chromatography system, and improper extension of retest dates for starting materials without additional testing. These findings indicate a need for improved quality control and data integrity practices.
- Inspection Date
- November 14, 2022
- Product Type
- Drugs
ID · 986c56e6-5168-45f3-8356-c967f620b5af