# FDA 483 - Fresenius Medical Care, North America - August 13, 2020

Source: https://www.globalkeysolutions.net/records/483/fresenius-medical-care-north-america/f722a98a-9b92-40b1-8c0a-5c07ebf6c6a6

> FDA 483 for Fresenius Medical Care, North America on August 13, 2020. 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: 2020-08-13
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Fresenius Medical Care, North America in Ogden, UT, a sterile drug manufacturer, was cited for two observations during an FDA inspection. The firm failed to thoroughly investigate unexplained discrepancies related to rejected batches and lacked adequate written procedures for production and process controls. These deficiencies included issues with retaining critical alarm logs and controlling certificates of analysis.

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

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