# FDA 483 - Ferring Pharmaceuticals (China) Co., Ltd - August 22, 2025

Source: https://www.keypedia.com/records/483/ferring-pharmaceuticals-china-co-ltd/17422f02-e35b-4016-8942-7745143337fc

> FDA 483 for Ferring Pharmaceuticals (China) Co., Ltd on August 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ferring Pharmaceuticals (China) Co., Ltd
- Inspection Date: 2025-08-22
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Ferring Pharmaceuticals (China) Corporation Ltd., a sterile diluent manufacturer in Zhongshan, China, revealed significant deficiencies. Observations included issues with equipment design and qualification, specifically bent components lacking individual IDs and capping machine qualification based on unscientific justification. Additionally, the firm lacked appropriate controls over computer systems, with unverified and undocumented backups of manufacturing data.

## Related Officers

- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.keypedia.com/companies/ferring-pharmaceuticals-china-co-ltd/fbe49136-eab7-4359-bfdb-ac0d5c2993f4

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