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1275862

DSC Laboratories, Inc. — FEI 1831691

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 16, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Muskegon, MI (United States)

Facility

Other inspections at this facility

  • 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))
  • 797219 (VAI Fri Aug 31 2012 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
126321 CFR 211.68(b)Computer control of master formula records
191421 CFR 211.166(a)Lack of written stability program
202821 CFR 211.192Extent of discrepancy, failure investigations
203321 CFR 211.194(c)Testing and standardization of standards et. al.
360321 CFR 211.160(b)Scientifically sound laboratory controls
434221 CFR 211.142(b)Storage under appropriate conditions