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Warning Letter

Case 597260 — FEI 1000513229

Facility

Recent inspections

  • 933726 (NAI Thu May 28 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 859795 (NAI Thu Dec 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 790639 (NAI Fri Jun 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 615049 (VAI Tue Sep 29 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Alkermes, Inc.
Date
December 2, 2019
Fiscal Year
2020
Product Type
Drugs
Center
CDER
Location
Waltham, MA (United States)