Covis Pharma GmBH – FDA EIR, Apr 5, 2019

AMAG Pharmaceuticals, Inc. underwent a routine FDA Postmarketing Adverse Drug Experience (PADE) inspection in Waltham, MA, from April 2-5, 2019. The inspection, conducted under the Bioresearch Monitoring Compliance Program Guidance, focused on PADE reporting for the company's products MAKENA, FERAHEME, and INTRAROSA. Notably, this inspection concluded without the issuance of any Form FDA 483 Inspectional Observations, signifying no new deficiencies were identified. The FDA investigator explicitly stated that AMAG had adequately addressed the issues cited in their previous PADE inspection from July 2016. Those prior observations involved delays in reporting serious and unexpected adverse drug experiences, inadequate investigation of 15-day postmarketing reports, and insufficient written procedures for adverse event evaluation. AMAG responded by overhauling its pharmacovigilance team and implementing new standard operating procedures. While no violations were observed, discussions with management included a single adverse event case being mislabeled and the 2018 Makena Periodic Safety Update Report's Appendix E potentially misleadingly excluding 15-day follow-up reports. The firm indicated they would review procedures to enhance reporting clarity.