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

Source: https://www.keypedia.com/records/483/chengdu-shengnuo-biopharm-co-ltd/3a5fc8ce-c04d-40a6-8c94-70d6a944c6dc

> FDA 483 for Chengdu Shengnuo Biopharm Co Ltd on September 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chengdu Shengnuo Biopharm Co Ltd
- Inspection Date: 2023-09-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

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Company: https://www.keypedia.com/companies/chengdu-shengnuo-biopharm-co-ltd/7e22dc83-be1b-41e1-af8c-856dd7a35375

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1