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1259656

Oasis Medical, Inc. — FEI 2083373

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 27, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Glendora, CA (United States)

Facility

Other inspections at this facility

  • 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))
  • 875200 (NAI Mon Apr 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113421 CFR 211.25(b)Supervisor Training/Education/Experience
117721 CFR 211.63Equipment Design, Size and Location
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
141321 CFR 211.42(c)(5)Mfg / Processing Operations Area
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
360321 CFR 211.160(b)Scientifically sound laboratory controls