483
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. LtdCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd – FDA 483, Nov 11, 2025
Record Details
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd, a manufacturer of sterile drug products, was cited for significant deficiencies during an FDA inspection. Observations included inadequate validation of aseptic processes, insufficient cleaning and disinfection protocols, and failures in environmental monitoring. Additionally, the firm was found to have poor documentation practices for production and process control procedures.
- Inspection date
- November 11, 2025
- Product type
- drugs
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ID · cb3c576d-a3b4-4b2b-b946-44625f6abff5
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