# FDA 483 - Zhejiang Ruibang Laboratories Co., Ltd - July 21, 2016

Source: https://www.globalkeysolutions.net/records/483/zhejiang-ruibang-laboratories-co-ltd/d2330795-5bd9-4fc1-98e5-12ca9df292ea

> FDA 483 for Zhejiang Ruibang Laboratories Co., Ltd on July 21, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Ruibang Laboratories Co., Ltd
- Inspection Date: 2016-07-21
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Zhejiang Ruibang Laboratories, an API manufacturer in Wenzhou, China, revealed significant deficiencies in their quality control systems. Observations included failures in computerized system data integrity, lack of scientifically sound sampling plans for materials, and inadequate investigation and documentation of deviations. These issues indicate a concerning lack of control over critical manufacturing and quality processes.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.globalkeysolutions.net/companies/zhejiang-ruibang-laboratories-co-ltd/d492de6c-b477-4077-b11f-1b6185504623

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