# FDA 483 - Shouguang Fukang Pharmaceutical Co., Ltd. - May 25, 2018

Source: https://www.globalkeysolutions.net/records/483/shouguang-fukang-pharmaceutical-co-ltd/25438b4e-e486-45ca-bb27-9e118d5276a1

> FDA 483 for Shouguang Fukang Pharmaceutical Co., Ltd. on May 25, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shouguang Fukang Pharmaceutical Co., Ltd.
- Inspection Date: 2018-05-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Shouguang Fukang Pharmaceutical Co., Ltd., an API manufacturer in Shouguang City, China, was cited for significant quality control and manufacturing deficiencies during an FDA inspection. Findings included unreliable laboratory data, commercial release of drug substances failing specifications without adequate investigation, and unsanitary conditions in both manufacturing equipment and storage areas. Additionally, the firm failed to maintain clean laboratory glassware.

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## Related Officers

- [Saleem A. Akhtar](https://www.globalkeysolutions.net/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

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