Qilu Antibiotics Pharmaceutical Co. , Ltd.May 30, 2023

FDA 483 - Qilu Antibiotics Pharmaceutical Co. , Ltd. - May 30, 2023

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Record Details

Qilu Antibiotics Pharmaceutical Co., LTD. in Licheng District, Shandong, was inspected and found to have significant deficiencies in its manufacturing processes for sterile drug products. The inspection revealed failures in aseptic processing simulations, environmental control systems, laboratory controls, and quality unit training procedures, indicating a high severity of non-compliance with sterile manufacturing regulations.

Company: Qilu Antibiotics Pharmaceutical Co. , Ltd.
Inspection Date: May 30, 2023
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: Suzanne N. Vallez
Cynthia Jim

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ID · ea74fdfa-9617-4364-b095-fabb92116823