483
Chunghwa Chemical Synthesis & Biotech Co., LtdChunghwa Chemical Synthesis & Biotech Co., Ltd – FDA 483, Apr 12, 2024
Record Details
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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ID · 311a988d-b487-4738-932f-19118ab1ca49
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