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957238

Aplicare Products, LLC — FEI 1220701

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 15, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Meriden, CT (United States)

Facility

Other inspections at this facility

  • 1147759 (OAI Tue Aug 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988787 (VAI Fri Sep 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 903219 (VAI Mon Nov 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 876204 (NAI Fri Apr 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 797580 (VAI Thu Sep 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
181021 CFR 211.160(a)Lab controls established, including changes
202721 CFR 211.192Investigations of discrepancies, failures
330921 CFR 820.120(b)Examination for accuracy