# FDA 483 - Zhuhai United Laboratories Co. Ltd. - July 16, 2019

Source: https://www.globalkeysolutions.net/records/483/zhuhai-united-laboratories-co-ltd/530097df-5ce0-4ee1-9d58-9e0e17fe9cf7

> FDA 483 for Zhuhai United Laboratories Co. Ltd. on July 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhuhai United Laboratories Co. Ltd.
- Inspection Date: 2019-07-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: This FDA Form 483 was issued to Zhuhai United Laboratories Co., Ltd. in Zhuhai, China, a manufacturer of sterile and non-sterile APIs and finished drugs. The inspection revealed significant deficiencies in quality control, laboratory procedures, data integrity, and environmental monitoring, particularly concerning out-of-specification investigations and data management. These issues indicate a lack of robust controls to ensure the quality and sterility of drug products.

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## Related Officers

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- [Compliance Officer](https://www.globalkeysolutions.net/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

Company: https://www.globalkeysolutions.net/companies/zhuhai-united-laboratories-co-ltd/4ba311e5-538b-4b2b-84a3-eaae689034c5

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