# FDA 483 - Zhejiang Ruibang Laboratories Co., Ltd - September 11, 2023

Source: https://www.globalkeysolutions.net/records/483/zhejiang-ruibang-laboratories-co-ltd/b926ccb6-be52-4176-ba7d-501fac1f87bc

> FDA 483 for Zhejiang Ruibang Laboratories Co., Ltd on September 11, 2023. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Ruibang Laboratories Co., Ltd
- Inspection Date: 2023-09-11
- Product Type: veterinary
- Office Name: Center for Veterinary Medicine
- Summary: Zhejiang Ruibang Laboritories Co., Ltd., an animal drug API manufacturer in Wenzhou, China, was cited for significant deficiencies across its operations. The inspection revealed issues with validation processes, inadequate laboratory methods and procedures, insufficient raw material identity testing, poor equipment maintenance, and inadequate pest control. These findings indicate a lack of robust quality systems and controls, posing potential risks to product quality and safety.

## Related Documents

- [483 - 2016-07-21](https://www.globalkeysolutions.net/records/483/zhejiang-ruibang-laboratories-co-ltd/d2330795-5bd9-4fc1-98e5-12ca9df292ea)
- [483 - 2024-10-25](https://www.globalkeysolutions.net/records/483/zhejiang-ruibang-laboratories-co-ltd/bc223e63-c629-41af-b347-aeb897557228)

## Related Officers

- [Younkun Kim](https://www.globalkeysolutions.net/people/younkun-kim/dc4dba46-db6a-4711-9a6c-f34ba57039ce)
- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

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

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4
