# FDA 483 - Chunghwa Chemical Synthesis & Biotech Co., Ltd - April 12, 2024

Source: https://www.keypedia.com/records/483/chunghwa-chemical-synthesis-biotech-co-ltd/311a988d-b487-4738-932f-19118ab1ca49

> FDA 483 for Chunghwa Chemical Synthesis & Biotech Co., Ltd on April 12, 2024. 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: 2024-04-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Chunghwa Chemical Synthesis & Biotech Co., LTD., an API manufacturer, revealed significant deficiencies in their quality systems. Observations included failures in establishing written procedures for process monitoring and validation, inadequate investigation records for critical deviations and out-of-specification events, and a lack of control over quality unit responsibilities and electronic data storage.

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## Related Officers

- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.keypedia.com/companies/chunghwa-chemical-synthesis-biotech-co-ltd/4c8ab291-0275-4884-960a-f5b3bc604eff

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