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1083919

McGuff Pharmaceuticals, Inc. — FEI 2022073

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 26, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Santa Ana, CA (United States)

Facility

Other inspections at this facility

  • 1268175 (OAI Mon Apr 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229677 (NAI Tue Aug 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1110847 (VAI Fri Nov 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1013240 (NAI Fri Jun 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 908368 (OAI Wed Dec 31 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
119421 CFR 211.42(c)Defined areas of adequate size for operations
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
439121 CFR 211.180(e)(2)Items to cover on annual reviews