FDA inspection

Genesiscare: FDA inspection ending Mar 12, 2018

FDA inspection 1044785 · Voluntary Action Indicated (VAI) · Naples, FL

Key facts

Inspection ID 1044785
Firm Genesiscare
FEI number 3007009870
Address 733 4th Ave N
City Naples
State FL
ZIP 34102
Country United States
Fiscal year 2018
Inspection end date Mar 12, 2018
Classification Voluntary Action Indicated (VAI)
Project area Blood and Blood Products
Product type Biologics

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • No 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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