# FDA 483 - Fujian Kerui Pharmaceutical Co., Ltd. - March 14, 2018

Source: https://www.globalkeysolutions.net/records/483/fujian-kerui-pharmaceutical-co-ltd/ae1f0267-59d2-404d-8585-8fd6130bad86

> FDA 483 for Fujian Kerui Pharmaceutical Co., Ltd. on March 14, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fujian Kerui Pharmaceutical Co., Ltd.
- Inspection Date: 2018-03-14
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Fujian Kerui Pharmaceutical Co., Ltd. in Fuqing, China, revealed issues with laboratory controls. Specifically, the firm failed to adequately document stability monitoring for active pharmaceutical ingredients. This indicates a lack of proper record-keeping for critical quality control processes.

## Related Officers

- [Tiara N Brown-Crosen](https://www.globalkeysolutions.net/people/tiara-n-brown-crosen/8255649d-25a9-49fa-a28d-0cdda922c0c3)

Company: https://www.globalkeysolutions.net/companies/fujian-kerui-pharmaceutical-co-ltd/ca7cfbfd-7fac-4f69-9852-a3a85ade2ade

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