483
Chunghwa Chemical Synthesis & Biotech Co., LtdChunghwa Chemical Synthesis & Biotech Co., Ltd – FDA 483, Nov 14, 2022
Record Details
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
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ID · 986c56e6-5168-45f3-8356-c967f620b5af
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