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1170966

ARx LLC — FEI 2528933

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 3, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Glen Rock, PA (United States)

Facility

Other inspections at this facility

  • 1151907 (NAI Fri Aug 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1085673 (VAI Fri Mar 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988507 (NAI Thu Aug 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 867422 (NAI Tue Feb 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 737192 (NAI Fri Jul 29 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
202821 CFR 211.192Extent of discrepancy, failure investigations
354721 CFR 211.46(b)Equipment for Environmental Control
358521 CFR 211.110(a)Control procedures to monitor and validate performance
436921 CFR 211.188(b)(11)Identification of persons involved, each significant step