FDA inspection

Fougera Pharmaceuticals LLC: FDA inspection ending Nov 10, 2016

FDA inspection 992924 · Voluntary Action Indicated (VAI) · Melville, NY

Key facts

Inspection ID 992924
Firm Fougera Pharmaceuticals LLC
FEI number 2432435
Address 60 Baylis Rd
City Melville
State NY
ZIP 11747
Country United States
Fiscal year 2017
Inspection end date Nov 10, 2016
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • None 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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