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702914

Impax Laboratories, LLC. — FEI 3004182921

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 21, 2011
Fiscal Year
2011
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
120721 CFR 211.65(b)Substances That Come in Contact
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
135821 CFR 211.100(b)SOPs not followed / documented
194321 CFR 211.180(e)(1)Review of representative number of batches
200821 CFR 211.186(a)Written procedures followed
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
436621 CFR 211.188(a)Accurate reproduction included