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1294966

Life Science Outsourcing, Inc. — FEI 3001236549

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 11, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Brea, CA (United States)

Facility

Other inspections at this facility

  • 1132829 (VAI Thu Nov 12 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 976086 (VAI Thu Jun 30 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 871800 (NAI Thu Mar 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 720864 (NAI Wed Apr 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 564994 (VAI Tue Feb 24 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls