# FDA 483 - Yaopharma Co Ltd - March 29, 2019

Source: https://www.keypedia.com/records/483/yaopharma-co-ltd/89ad204e-a928-4924-bab9-693f53b6078f

> FDA 483 for Yaopharma Co Ltd on March 29, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yaopharma Co Ltd
- Inspection Date: 2019-03-29
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Yaopharma Co Ltd in Chongqing, China, revealed a significant issue with data integrity and adherence to written procedures. Specifically, an analyst failed to follow standard operating procedures for recording data, leading to discrepancies in laboratory notebooks and investigation results. This indicates a breakdown in quality control and reliable record-keeping practices.

## Related Officers

- [investigator](https://www.keypedia.com/people/jose-o-hernandez/960bffbe-1b8e-41bc-b203-aee88d7d8dac)

Company: https://www.keypedia.com/companies/yaopharma-co-ltd/2dc9295c-1e0b-4d74-b348-66f36b4e7782

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