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1147759

Aplicare Products, LLC — FEI 1220701

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 3, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Meriden, CT (United States)

Facility

Other inspections at this facility

  • 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))
  • 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
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
354721 CFR 211.46(b)Equipment for Environmental Control