FDA 483 - Covis Pharma GmBH - February 07, 2013

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.