483
Zhejiang Anglikang Pharmaceutical Co., Ltd.Zhejiang Anglikang Pharmaceutical Co., Ltd. – FDA 483, Nov 21, 2025
Record Details
Zhejiang Anglikang Pharmaceutical Co., Ltd. in Shaoxing, China, was inspected regarding its sterile drug product manufacturing. The inspection revealed significant deficiencies across aseptic processing, environmental monitoring, batch recordkeeping, laboratory controls, and component management. These issues indicate a high risk of microbiological contamination and data integrity concerns, impacting the quality and sterility assurance of drug products intended for the US market.
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ID · 9e04c03c-b851-4df5-b361-660744381190
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