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804857

CMP Pharma Inc — FEI 1050589

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 24, 2012
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Farmville, NC (United States)

Facility

Other inspections at this facility

  • 1217480 (VAI Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1196186 (NAI Wed Jan 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061287 (VAI Thu Jun 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023838 (NAI Thu May 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1001769 (VAI Wed Dec 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
358221 CFR 211.105(a)Identification of containers, lines, equipment
434221 CFR 211.142(b)Storage under appropriate conditions
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
441521 CFR 211.204Returned drug products with doubt cast as to safety et. al.
457621 CFR 211.192No written record of investigation