# FDA 483 - Shanghai Co-Fun Biotech Corp., Ltd. - March 21, 2019

Source: https://www.globalkeysolutions.net/records/483/shanghai-co-fun-biotech-corp-ltd/a7211c65-e7fd-442d-889b-eb95d58a9ab1

> FDA 483 for Shanghai Co-Fun Biotech Corp., Ltd. on March 21, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shanghai Co-Fun Biotech Corp., Ltd.
- Inspection Date: 2019-03-21
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Shanghai Co-Fun Biotech Corporation, Ltd. in Shanghai, China, revealed severe and systemic data integrity issues, including widespread falsification of GMP documents. The firm's Quality Unit was found to have misled investigators, forged numerous records, and lacked effective oversight, indicating a profound failure to adhere to current Good Manufacturing Practices for Active Pharmaceutical Ingredients. This included falsified stability programs, process validation, laboratory testing data, and employee training records, often prepared and backdated just prior to the inspection.

## Related Officers

- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

Company: https://www.globalkeysolutions.net/companies/shanghai-co-fun-biotech-corp-ltd/6781836f-06ee-49df-9cf9-c42522e0bd90

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd