# FDA 483 - Fresenius Medical Care, North America - March 06, 2026

Source: https://www.keypedia.com/records/483/fresenius-medical-care-north-america/56ddc6fe-5fe3-4e2c-9d6f-ac45fbd071d7

> FDA 483 for Fresenius Medical Care, North America on March 06, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Medical Care, North America
- Inspection Date: 2026-03-06
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Fresenius USA Manufacturing, Inc. in Ogden, UT, a sterilized drug manufacturer, revealed two significant observations. The firm's investigation records for batch failures, specifically regarding pinholes in primary bags, lacked complete conclusions and follow-up. Additionally, the company failed to establish adequate written procedures for production and process controls, particularly concerning the qualification of inspectors for routine 100% visual inspection of sterile drugs.

## Related Documents

- [WARNING_LETTER - 2012-12-07](https://www.keypedia.com/records/warning_letter/fresenius-medical-care-north-america/13ad9f83-444c-496f-9ebe-aabaadfbd30b)
- [483 - 2020-08-13](https://www.keypedia.com/records/483/fresenius-medical-care-north-america/f722a98a-9b92-40b1-8c0a-5c07ebf6c6a6)
- [483 - 2021-05-21](https://www.keypedia.com/records/483/fresenius-medical-care-north-america/e6d7cf63-c9b4-419b-8dad-1febdcab29cf)

## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

Company: https://www.keypedia.com/companies/fresenius-medical-care-north-america/90cbe724-7310-49e8-983b-b062488d9710

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face