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797580

Aplicare Products, LLC — FEI 1220701

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 6, 2012
Fiscal Year
2012
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))
  • 957238 (OAI Fri Jan 15 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))

Recent compliance actions

Citations

IDCFRDescription
145021 CFR 211.113(a)Procedures for non-sterile drug products
181021 CFR 211.160(a)Lab controls established, including changes
194321 CFR 211.180(e)(1)Review of representative number of batches
202721 CFR 211.192Investigations of discrepancies, failures
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.