# FDA 483 - Covis Pharma GmBH - August 03, 2011

Source: https://www.keypedia.com/records/483/covis-pharma-gmbh/55b430c0-50f3-46db-9e52-cf8160c30b8d

> FDA 483 for Covis Pharma GmBH on August 03, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Covis Pharma GmBH
- Inspection Date: 2011-08-03
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: AMAG Pharmaceuticals, Inc. in Lexington, MA, was cited for multiple deficiencies related to its drug product, Gastromark. The inspection revealed failures in thoroughly reviewing discrepancies, conducting timely annual product reviews, and submitting required reports to the FDA. These issues include delayed field alert reports, and late annual adverse drug experience and general annual reports.

## Related Documents

- [483 - 2013-02-07](https://www.keypedia.com/records/483/covis-pharma-gmbh/63a7c09e-9210-463a-8653-f60b4b6c0244)
- [483 - 2014-05-21](https://www.keypedia.com/records/483/covis-pharma-gmbh/d31460cb-08fd-45a3-ab4d-1dbc66de56ec)

## Related Officers

- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.keypedia.com/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)
- [investigator](https://www.keypedia.com/people/stacey-s-degarmo/f0dea08e-f65f-4664-9614-66f1997a95dc)

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

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