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949687

Denker, Mark S, MD PA — FEI 3004450713

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 18, 2015
Fiscal Year
2016
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Boca Raton, FL (United States)

Facility

Other inspections at this facility

  • 1207527 (NAI Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1171177 (NAI Mon Jun 06 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 755670 (NAI Mon Dec 05 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 598743 (NAI Thu Jul 23 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1222921 CFR 1271.50(a)Determination based on screening and testing
1223121 CFR 1271.50(b)(1)Donor screening standards
1227221 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results