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797219

DSC Laboratories, Inc. — FEI 1831691

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 31, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Muskegon, MI (United States)

Facility

Other inspections at this facility

  • 1275862 (VAI Wed Jul 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028372 (VAI Wed Oct 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 944315 (VAI Tue Aug 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 731711 (VAI Mon Jun 27 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 656959 (VAI Tue Apr 13 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
180921 CFR 211.160(a)Following/documenting laboratory controls
188321 CFR 211.165(a)Testing and release for distribution
200921 CFR 211.188Prepared for each batch, include complete information
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action