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1016973

Vivex Biologics, Inc. — FEI 1000113913

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 6, 2017
Fiscal Year
2017
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Miami, FL (United States)

Facility

Other inspections at this facility

  • 1226932 (VAI Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1176417 (VAI Thu Aug 04 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067763 (NAI Fri Sep 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 951971 (VAI Fri Dec 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 863049 (NAI Fri Dec 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1232521 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
1237321 CFR 1271.200(d)Inspected routinely
1238721 CFR 1271.220(a)Causing contamination, increasing risks
1239821 CFR 1271.230(a)Validation & approval--established procedures