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1100556

Evologics, LLC — FEI 3007950315

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 27, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
San Antonio, TX (United States)

Facility

Other inspections at this facility

  • 1147505 (VAI Tue Jul 27 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 993000 (NAI Wed Nov 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 823285 (NAI Wed Mar 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 695110 (NAI Thu Oct 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1243321 CFR 1271.265(f)Return to inventory--procedures
1243621 CFR 1271.270(a)Accurate, indelible, legible
1243721 CFR 1271.270(a)Records incomplete
1245321 CFR 1271.290(e)Documenting disposition of each HCT/P
1245821 CFR 1271.320(b)Designated complaint file
1247021 CFR 1271.350(a)(2)15 day reporting timeframe