Home / Inspections / 946186

946186

ABCO Laboratories, Inc. — FEI 1000142677

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 25, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Fairfield, CA (United States)

Facility

Other inspections at this facility

  • 1121962 (VAI Fri Mar 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1049381 (VAI Wed Apr 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042098 (NAI Wed Feb 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 903900 (VAI Tue Nov 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 880906 (NAI Fri May 30 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
144921 CFR 211.111Deviations of production time limits
155021 CFR 211.125(f)Procedures Written and Followed
172821 CFR 211.87Retest of approved components/containers/closures
202721 CFR 211.192Investigations of discrepancies, failures
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
358521 CFR 211.110(a)Control procedures to monitor and validate performance
430621 CFR 211.80(a)Written Procedures Not Followed
430721 CFR 211.80(d)Status of Each Lot Identified
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action