# FDA 483 - Fresenius Medical Care Holdings, Inc. - August 02, 2019

Source: https://www.keypedia.com/records/483/fresenius-medical-care-holdings-inc/82ea8526-06b8-46bd-acb8-311eb8ac0584

> FDA 483 for Fresenius Medical Care Holdings, Inc. on August 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Medical Care Holdings, Inc.
- Inspection Date: 2019-08-02
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Fresenius Medical Care Holdings, Inc.'s Corporate Headquarters in Waltham, MA, revealed significant deficiencies in adverse drug experience reporting. The firm failed to report several serious and unexpected adverse drug experiences to the FDA within the required 15-day timeframe. Additionally, the company submitted Individual Case Safety Reports (ICSRs) that omitted critical adverse drug experience terms.

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## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)
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Company: https://www.keypedia.com/companies/fresenius-medical-care-holdings-inc/71c8f1ab-77b5-4c59-ad13-3f0de5b7a6f3

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94