# FDA 483 - Covis Pharma GmBH - February 07, 2013

Source: https://www.keypedia.com/records/483/covis-pharma-gmbh/63a7c09e-9210-463a-8653-f60b4b6c0244

> FDA 483 for Covis Pharma GmBH on February 07, 2013. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Covis Pharma GmBH
- Inspection Date: 2013-02-07
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: AMAG Pharmaceuticals, Inc. in Lexington, MA, was cited for failing to submit NDA-Field Alert Reports within the required three working days. This inspection revealed delays in reporting out-of-specification results for Feraheme and the distribution of GastroMARK products with unapproved packaging changes. These failures indicate significant non-compliance with regulatory reporting requirements for distributed drug products.

## Related Documents

- [483 - 2011-08-03](https://www.keypedia.com/records/483/covis-pharma-gmbh/55b430c0-50f3-46db-9e52-cf8160c30b8d)
- [483 - 2014-05-21](https://www.keypedia.com/records/483/covis-pharma-gmbh/d31460cb-08fd-45a3-ab4d-1dbc66de56ec)

## Related Officers

- [CSO at FDA](https://www.keypedia.com/people/justine-m-corson/5f6e4477-f060-47f1-9165-a63fd6a36226)

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