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1221397

Alkermes Inc — FEI 1000142940

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 19, 2023
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Wilmington, OH (United States)

Facility

Other inspections at this facility

  • 1023169 (NAI Mon Aug 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 934564 (NAI Fri Apr 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 892884 (NAI Fri Aug 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 876673 (NAI Wed Apr 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 850614 (NAI Mon Sep 23 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
125621 CFR 211.68(b)Backup file not maintained
126321 CFR 211.68(b)Computer control of master formula records
145221 CFR 211.113(b)Validation lacking for sterile drug products
360321 CFR 211.160(b)Scientifically sound laboratory controls
438821 CFR 211.198(a)Complaints reviewed by Quality Control Unit