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730683

Biochem Laboratory, Inc. — FEI 3005094136

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 15, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lyndhurst, NJ (United States)

Facility

Other inspections at this facility

  • 1276819 (VAI Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083917 (VAI Tue Mar 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 882449 (VAI Tue Jun 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 779784 (VAI Mon May 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 671029 (VAI Fri Jul 09 2010 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
126321 CFR 211.68(b)Computer control of master formula records
180921 CFR 211.160(a)Following/documenting laboratory controls
189021 CFR 211.165(e)Test methods
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
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
441021 CFR 211.194(a)(5)Calculations performed are in the records
441221 CFR 211.194(a)(7)Signatures and dates--person who performs test