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Warning Letter

Case 643090 — FEI 3004450713

Facility

Recent inspections

  • 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))
  • 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))

Action Details

Facility
Denker, Mark S, MD PA
Date
November 17, 2022
Fiscal Year
2023
Product Type
Biologics
Center
CBER
Location
Boca Raton, FL (United States)