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788941

Oasis Medical, Inc. — FEI 2083373

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 26, 2012
Fiscal Year
2012
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))
  • 1071867 (VAI Fri Nov 16 2018 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))

Recent compliance actions

Citations

IDCFRDescription
145221 CFR 211.113(b)Validation lacking for sterile drug products
188321 CFR 211.165(a)Testing and release for distribution
191821 CFR 211.166(a)(2)Stability sample storage conditions described
192021 CFR 211.166(a)(3)Valid stability test methods
193221 CFR 211.167(a)Sterility/pyrogen-free testing
360321 CFR 211.160(b)Scientifically sound laboratory controls
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
435921 CFR 211.170(b)(1)Retention time of reserve samples, in general