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903900

ABCO Laboratories, Inc. — FEI 1000142677

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 4, 2014
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))
  • 946186 (VAI Fri Sep 25 2015 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
180921 CFR 211.160(a)Following/documenting laboratory controls
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
360321 CFR 211.160(b)Scientifically sound laboratory controls
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
438921 CFR 211.198(a)Procedures to be written and followed