# FDA 483 - Lonza Guangzhou Pharmaceutical Ltd. - October 31, 2025

Source: https://www.globalkeysolutions.net/records/483/lonza-guangzhou-pharmaceutical-ltd/b9411a55-c9a2-446b-b943-96edfbf389b1

> FDA 483 for Lonza Guangzhou Pharmaceutical Ltd. on October 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Guangzhou Pharmaceutical Ltd.
- Inspection Date: 2025-10-31
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Lonza Guangzhou Pharmaceutical Ltd., an API manufacturer in Nansha District, China, revealed significant deficiencies in its quality unit operations. The firm released API batches to the U.S. market without ensuring safety levels of impurities and conducted inadequate complaint investigations for foreign matter. Additionally, the quality system for approving contract laboratories performing critical impurity testing was found to be deficient.

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## Related Officers

- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.globalkeysolutions.net/companies/lonza-guangzhou-pharmaceutical-ltd/eeb8d307-3663-4559-88cd-4e0696c0b556

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