# FDA 483 - Zhuhai United Laboratories Co. Ltd. - March 23, 2026

Source: https://www.keypedia.com/records/483/zhuhai-united-laboratories-co-ltd/ee58ad81-b273-4b6e-bb51-d28551d698f6

> FDA 483 for Zhuhai United Laboratories Co. Ltd. on March 23, 2026. 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: 2026-03-23
- Product Type: drugs
- Office Name: Division of Inspectional Assessment
- Summary: The FDA inspection of Zhuhai United Laboratories Co., Ltd. in Zhuhai, China, revealed significant deficiencies across multiple areas of its pharmaceutical manufacturing operations. Key issues include inadequate aseptic process simulations, ineffective environmental monitoring, and a lack of proper validation for critical equipment and sterilization processes. The firm also demonstrated poor quality assurance oversight and ineffective employee training, indicating a broad failure to adhere to GMP standards for sterile drug products and sterile API.

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## Related Officers

- [Thomas J. Arista](https://www.keypedia.com/people/thomas-j-arista/37905892-3285-4f3f-b4b5-f963df1e59d3)

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

Office: https://www.keypedia.com/offices/division-of-inspectional-assessment/9bc7aff2-93a7-404a-8015-0f93c3701c13