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774547

Impax Laboratories, LLC. — FEI 3004182921

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 28, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hayward, CA (United States)

Facility

Other inspections at this facility

  • 1080691 (NAI Fri Jan 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023293 (NAI Wed Aug 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 974379 (VAI Wed May 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 929678 (VAI Fri May 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 888881 (VAI Thu Jul 31 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
189121 CFR 211.165(f)Failing drug products not rejected
202821 CFR 211.192Extent of discrepancy, failure investigations
435521 CFR 211.165(c)Sampling and testing plans not followed
457621 CFR 211.192No written record of investigation