# FDA 483 - Suzhou Xishan Zhongke Drug R&D, Co. Ltd. - May 10, 2024

Source: https://www.keypedia.com/records/483/suzhou-xishan-zhongke-drug-rd-co-ltd/45af84ab-48eb-4ecf-aa90-c57445dfe402

> FDA 483 for Suzhou Xishan Zhongke Drug R&D, Co. Ltd. on May 10, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Suzhou Xishan Zhongke Drug R&D, Co. Ltd.
- Inspection Date: 2024-05-10
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Suzhou Xishan Zhongke Drug R&D, Co. Ltd., a nonclinical laboratory in Suzhou, revealed significant deficiencies in their operations. Observations included inadequate archiving and access controls for study records, insufficient written standard operating procedures for data quality, and failures in quality assurance unit responsibilities and equipment maintenance.

## Related Officers

- [Deborah A. Greco](https://www.keypedia.com/people/deborah-a-greco/38e393b5-55c4-461c-a0b0-4937e0cbec37)
- [EunClem](https://www.keypedia.com/people/eunclem/daf89606-e9c3-497a-a69c-82b79a33ddcf)

Company: https://www.keypedia.com/companies/suzhou-xishan-zhongke-drug-rd-co-ltd/dc890450-dcf3-4418-9b62-8b22b6de1182

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