FDA inspection

Mark S. Denker, MD PA: FDA inspection ending Jun 6, 2022

FDA inspection 1171177 · Official Action Indicated (OAI) · Boca Raton, FL

Key facts

Inspection ID 1171177
Firm Mark S. Denker, MD PA
FEI number 3004450713
Address 7015 Beracasa Way Ste 201
City Boca Raton
State FL
ZIP 33433
Country United States
Fiscal year 2022
Inspection end date Jun 6, 2022
Classification Official Action Indicated (OAI)
Project area Blood and Blood Products
Product type Biologics
Warning letter 643090

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • Yes Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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