# FDA 483 - GE Healthcare Shanghai Co., Ltd. - October 30, 2025

Source: https://www.keypedia.com/records/483/ge-healthcare-shanghai-co-ltd/a1b12103-5208-4695-aeef-62a880f5039e

> FDA 483 for GE Healthcare Shanghai Co., Ltd. on October 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GE Healthcare Shanghai Co., Ltd.
- Inspection Date: 2025-10-30
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of GE Healthcare Shanghai Co. Ltd., a sterile drug manufacturer in Shanghai, China, revealed significant deficiencies across multiple areas. Observations included failures in retesting drug product container closures after contamination, inadequate cleaning and maintenance of equipment, and insufficient controls over computer systems for manufacturing data backup. These issues indicate a lack of robust quality control and data integrity practices.

## Related Officers

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

Company: https://www.keypedia.com/companies/ge-healthcare-shanghai-co-ltd/be6327f6-f1a1-40b7-8eb6-9955a9760762

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