# FDA 483 - Zhejiang Ruibang Laboratories Co., Ltd - October 25, 2024

Source: https://www.globalkeysolutions.net/records/483/zhejiang-ruibang-laboratories-co-ltd/bc223e63-c629-41af-b347-aeb897557228

> FDA 483 for Zhejiang Ruibang Laboratories Co., Ltd on October 25, 2024. 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: 2024-10-25
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Zhejiang Ruibang Laboratories in Wenzhou, China, was cited with four observations during an FDA inspection from October 21-25, 2024. The inspection revealed significant issues including inadequate investigation of out-of-specification results, unvalidated test methods, non-contemporaneous record-keeping, and a lack of written procedures for critical production processes. These findings indicate a need for improved quality control and documentation practices.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

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

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8