FDA EIR - Covis Pharma GmBH - August 03, 2011

An FDA inspection of AMAG Pharmaceuticals, Inc., located in Lexington, MA, occurred from July 26 to August 3, 2011. The inspection reviewed compliance with post-marketing adverse drug experience (ADE) reporting regulations and drug process requirements. The inspection identified several critical deficiencies, resulting in the issuance of an FDA Form 483. Key violations included the failure to thoroughly investigate an unexplained discrepancy related to incorrect Gastromark drug product labels (stating 175 mg/ml instead of 175 mcg/ml of iron), which were distributed for three years without corrective action. The company also failed to conduct Annual Product Reviews for Gastromark since 2007 and submitted an NDA Field Alert for the labeling error significantly beyond the mandated three-working-day timeframe. Furthermore, AMAG Pharmaceuticals, Inc. was found to have submitted Gastromark's annual periodic adverse drug experience reports and general annual reports late, exceeding the 60-day anniversary deadline. These observations indicate a need for improved quality control, timely regulatory submissions, and adherence to established procedures. The company is required to address these inspectional observations by implementing appropriate corrective actions to ensure full compliance with federal drug regulations.