Covis Pharma GmBH – FDA EIR, Feb 7, 2013

An FDA inspection of AMAG Pharmaceuticals, Inc. in Lexington, MA, was conducted from January 30 to February 7, 2013. The inspection, initiated by the CDER Pharmacovigilance Team, focused on compliance with Post Marketing Adverse Drug Experience (PADE) Regulations and the Drug Quality Reporting System for NDA Field Alert Reports (FARs), specifically referencing 21 CFR 314.81(b)(1)(ii).

The primary violation identified, resulting in a 1-item FDA-483, concerned the late submission of NDA Field Alert Reports. In one instance, AMAG Pharmaceuticals reported out-of-specification analytical results for its Feraheme drug product (Lot A56997A) nine working days after initial notification, exceeding the mandated three-working-day timeframe. Another issue involved GastroMARK products (Lots V601A, V602A, X600A) being distributed with an unapproved primary packaging change, with the FAR submitted four working days after notification. The FDA emphasized that reporting is required upon initial awareness, not after confirmation.

Additionally, recordkeeping inconsistencies were noted regarding the company's Spontaneous Adverse Event/Serious Adverse Event Case Review Forms, which management committed to addressing. As a required action, William K. Heiden, President & CEO, promised to submit a written response to the FDA New England District Office within 15 business days to address the identified regulatory observation.