# FDA 483 - Chunghwa Chemical Synthesis & Biotech Co., Ltd - November 14, 2022

Source: https://www.keypedia.com/records/483/chunghwa-chemical-synthesis-biotech-co-ltd/986c56e6-5168-45f3-8356-c967f620b5af

> FDA 483 for Chunghwa Chemical Synthesis & Biotech Co., Ltd on November 14, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chunghwa Chemical Synthesis & Biotech Co., Ltd
- Inspection Date: 2022-11-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

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Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1