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

Source: https://www.keypedia.com/records/483/chunghwa-chemical-synthesis-biotech-co-ltd/dd4b6f5f-69d7-41f6-8e1c-1692029fef41

> 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 Inspections and Investigations
- Summary: Chunghwa Chemical Synthesis & Biotech Co., LTD., an Active Pharmaceutical Ingredient (API) manufacturer, received an FDA Form 483 following an inspection conducted from April 8-12, 2024. The observations highlight significant deficiencies in the company's quality management system and adherence to Current Good Manufacturing Practices (cGMP). Key violations include a failure to establish robust written procedures for monitoring and controlling critical processing steps, leading to variability in intermediate and API quality. Specifically, process validation studies for a crude product were inadequately designed, resulting in significant moisture content variation and multiple Out-of-Specification (OOS) results, with root causes sometimes attributed to personnel variability. Furthermore, the company failed to consistently investigate critical deviations and OOS events, with investigations often not extending to potentially affected batches. Examples include an unaddressed microbial contamination in a water system, delayed customer notification for a stability OOS, and incomplete root cause analysis for cleaning failures. The FDA also noted that the Quality Unit's responsibilities and procedures were not adequately documented or followed. This was evidenced by uncontrolled electronic storage media, a lack of quality system trending for deviations and OOS events, and traceability gaps in corrective and preventive action (CAPA) implementation. To achieve compliance, Chunghwa Chemical Synthesis & Biotech Co., LTD. is required to promptly implement comprehensive corrective actions, including revising and enforcing written procedures for process control and validation, strengthening OOS investigation processes, ensuring timely customer notifications, and establishing a robust and fully documented quality unit system.

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## Related Officers

- [President](https://www.keypedia.com/people/patrick-wei/7009214e-7114-4ac5-9297-9fcc3faef5b1)
- [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-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8