# FDA 483 - GE Healthcare AS, Lindesnes Site - February 07, 2025

Source: https://www.keypedia.com/records/483/ge-healthcare-as-lindesnes-site/d716c89a-6298-4894-b72b-4ce720d284b1

> FDA 483 for GE Healthcare AS, Lindesnes Site on February 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GE Healthcare AS, Lindesnes Site
- Inspection Date: 2025-02-07
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: GE HealthCare, an API manufacturer in Lindesnes, Norway, received a Form 483 with three observations. The inspection revealed inadequate deviation investigations and CAPA actions for recurring endotoxin contamination in API intermediates. Additionally, the firm lacked appropriate controls to prevent drug substance contamination, including insufficient dust collector filtration and unprotected product containers, and failed to conduct annual product quality reviews within established timelines.

## Related Officers

- [Investigator](https://www.keypedia.com/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.keypedia.com/companies/ge-healthcare-as-lindesnes-site/03ef9999-6a2c-4a7d-87be-cad66c893639

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