FDA inspection

Fougera Pharmaceuticals, LLC.: FDA inspection ending Aug 8, 2019

FDA inspection 1099624 · Voluntary Action Indicated (VAI) · Hicksville, NY

Key facts

Inspection ID 1099624
Firm Fougera Pharmaceuticals, LLC.
FEI number 2410271
Address 55 Cantiague Rock Rd
City Hicksville
State NY
ZIP 11801
Country United States
Fiscal year 2019
Inspection end date Aug 8, 2019
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

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
  • 10–99 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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