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1276565

North American Science Associates, LLC — FEI 2020640

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 24, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Irvine, CA (United States)

Facility

Other inspections at this facility

  • 1271073 (NAI Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118132 (NAI Wed Jan 15 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 994018 (VAI Fri Dec 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 894092 (NAI Fri Sep 05 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844812 (VAI Mon Aug 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143621 CFR 211.42(c)(10)(vi)Equipment to control conditions
187921 CFR 211.180(c)Records not made readily available to FDA
194221 CFR 211.180(e)Records reviewed annually
202721 CFR 211.192Investigations of discrepancies, failures