# FDA 483 - Covis Pharma GmBH - May 21, 2014

Source: https://www.globalkeysolutions.net/records/483/covis-pharma-gmbh/d31460cb-08fd-45a3-ab4d-1dbc66de56ec

> FDA 483 for Covis Pharma GmBH on May 21, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Covis Pharma GmBH
- Inspection Date: 2014-05-21
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: AMAG Pharmaceuticals, Inc. in Waltham, MA, was inspected regarding its corporate headquarters operations. The inspection revealed significant deficiencies in investigations, equipment suitability, complaint handling, analytical methods, manufacturing environment controls, vendor auditing, and retain sample policies. These issues primarily concern the quality and safety of their Feraheme drug product.

## Related Documents

- [483 - 2011-08-03](https://www.globalkeysolutions.net/records/483/covis-pharma-gmbh/55b430c0-50f3-46db-9e52-cf8160c30b8d)
- [483 - 2013-02-07](https://www.globalkeysolutions.net/records/483/covis-pharma-gmbh/63a7c09e-9210-463a-8653-f60b4b6c0244)

## Related Officers

- [Megan A. Haggerty](https://www.globalkeysolutions.net/people/megan-a-haggerty/029fddce-aa3a-4959-9c5e-4684603bbc50)
- [Ramon E. Martinez](https://www.globalkeysolutions.net/people/ramon-e-martinez/9d3b4ce9-a11e-4c47-9e53-a5732ac13bdf)

Company: https://www.globalkeysolutions.net/companies/covis-pharma-gmbh/d1616a5d-a379-4021-b5aa-ef8f369c9a92

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