Covis Pharma GmBH – FDA 483, May 21, 2014

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.