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758746

Applied Consumer Services Inc. — FEI 3004957221

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 6, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hialeah Gardens, FL (United States)

Facility

Other inspections at this facility

  • 1288378 (VAI Mon Sep 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118304 (VAI Fri Feb 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1035494 (VAI Wed Dec 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 850475 (VAI Fri Sep 06 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
126321 CFR 211.68(b)Computer control of master formula records
189021 CFR 211.165(e)Test methods
197521 CFR 211.182Written records kept in individual logs
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
203321 CFR 211.194(c)Testing and standardization of standards et. al.
360321 CFR 211.160(b)Scientifically sound laboratory controls
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
900121 CFR 211.22(a)Lack of quality control unit