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1171177

Denker, Mark S, MD PA — FEI 3004450713

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 6, 2022
Fiscal Year
2022
Product Type
Biologics
Project Area
Blood and Blood Products
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))
  • 949687 (VAI Wed Nov 18 2015 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
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1223121 CFR 1271.50(b)(1)Donor screening standards
1223921 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
1224121 CFR 1271.55(b)(4)Reasons for ineligibility on summary
1224621 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
1227221 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence