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1274911

Pharmaceutical Specialties, Inc. — FEI 2150117

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 15, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Rochester, MN (United States)

Facility

Other inspections at this facility

  • 1091169 (VAI Fri May 03 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 867840 (NAI Wed Feb 26 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 564154 (NAI Fri Feb 20 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
184321 CFR 211.84(d)(2)Component written specification
188521 CFR 211.165(b)Microbiological testing
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified