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715478

Apex International Mfg., LLC — FEI 2130334

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 31, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chaska, MN (United States)

Facility

Other inspections at this facility

  • 1214939 (VAI Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1196639 (VAI Wed Jan 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030330 (VAI Tue Oct 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 937906 (NAI Tue Aug 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918226 (VAI Tue Jan 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
178721 CFR 211.80(a)Procedures To Be in Writing
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.