Chengdu Shengnuo Biopharm Co LtdSeptember 8, 2023

FDA 483 - Chengdu Shengnuo Biopharm Co Ltd - September 08, 2023

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Record Details

An FDA inspection of Chengdu Shengnuo Biopharm Co Ltd, a drug manufacturer in Chengdu, China, revealed significant deficiencies in the firm's quality unit regarding manufacturing records. The firm failed to ensure that records were complete, clear, accurate, contemporaneous, and traceable, leading to potential mix-ups, inadequate procedure adherence, and incomplete documentation.

Company: Chengdu Shengnuo Biopharm Co Ltd
Inspection Date: September 8, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Djamila Harouaka (Microbiologist)

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