# FDA 483 - Zhuhai United Laboratories Co. Ltd. - August 03, 2023

Source: https://www.globalkeysolutions.net/records/483/zhuhai-united-laboratories-co-ltd/ae16ada7-7e83-490f-ae71-a25c5f14a6ac

> FDA 483 for Zhuhai United Laboratories Co. Ltd. on August 03, 2023. 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: 2023-08-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Zhuhai United Laboratories, Co., Ltd. in Zhuhai, China, an API Intermediate Manufacturer, was inspected by the FDA. The inspection revealed significant deficiencies across quality control, laboratory practices, production records, and equipment maintenance. Key issues include inconsistent specifications with the Drug Master File, inadequate investigation of unexpected chromatographic occurrences, poor control of recovered solvents, incomplete laboratory and batch production records, deficient cleaning procedures, and unsuitable analytical testing methods.

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## Related Officers

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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