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1071867

Oasis Medical, Inc. — FEI 2083373

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 16, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Glendora, CA (United States)

Facility

Other inspections at this facility

  • 1259656 (OAI Mon Jan 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1075290 (NAI Fri Nov 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028717 (VAI Thu Sep 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941356 (NAI Fri Aug 28 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 875200 (NAI Mon Apr 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
191221 CFR 211.166(a)Written program not followed
360321 CFR 211.160(b)Scientifically sound laboratory controls
363221 CFR 211.170(b)Annual visual exams of drug products