483
Covis Pharma GmBHFDA 483 - Covis Pharma GmBH - February 07, 2013
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Record Details
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.
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ID · 63a7c09e-9210-463a-8653-f60b4b6c0244