CSPC Ouyi Pharmaceutical Co., Ltd.September 5, 2024

FDA 483 - CSPC Ouyi Pharmaceutical Co., Ltd. - September 05, 2024

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Record Details

CSPC Ouyi Pharmaceutical Co., Ltd. in Shijiazhuang, China, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in sterile drug product manufacturing, including inadequate sterilization process validation and environmental monitoring in aseptic areas. Additionally, the firm lacked proper data integrity controls for computerized systems and had issues with laboratory testing procedures and record review.

Company: CSPC Ouyi Pharmaceutical Co., Ltd.
Inspection Date: September 5, 2024
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Gam S. Zamil (issuing_officer)
Cynthia Jim

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ID · dbb2f15d-e046-43f7-b185-c8071e637f6e