# Wuhan Hongren Biopharmaceutical Inc. – FDA 483, Sep 4, 2024

Source: https://www.keypedia.com/records/483/wuhan-hongren-biopharmaceutical-inc/88832f27-179c-4d48-a03a-9d488c410758

> FDA 483 for Wuhan Hongren Biopharmaceutical Inc. on September 04, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wuhan Hongren Biopharmaceutical Inc.
- Inspection Date: 2024-09-04
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Wuhan Hongren Biopharmaceutical Inc., a contract testing laboratory in Wuhan, China, revealed significant deficiencies in quality control and data integrity. The firm failed to thoroughly investigate discrepancies, did not fully follow quality control unit procedures, and lacked appropriate controls over computer systems. Additionally, laboratory records were found to be deficient regarding test result comparisons to specifications.

## Related Officers

- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)

Company: https://www.keypedia.com/companies/wuhan-hongren-biopharmaceutical-inc/27dc633e-ae6d-4e67-b6a1-a5da5555215c

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8