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544384

IPR Pharmaceuticals, Inc. — FEI 3003009422

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 8, 2008
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Canovanas, PR (United States)

Facility

Other inspections at this facility

  • 1271831 (NAI Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1055499 (VAI Thu Jun 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 942102 (NAI Wed Aug 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844409 (VAI Mon Jul 29 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 701582 (NAI Tue Dec 07 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
361321 CFR 211.160(b)(4)Establishment of calibration procedures
434921 CFR 211.160(b)(2)In-process samples representative, identified properly