Fougera Pharmaceuticals, Inc.March 26, 2026

FDA 483 - Fougera Pharmaceuticals, Inc. - March 26, 2026

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Record Details

An FDA inspection of Fougera Pharmaceuticals, LLC. in Hicksville, NY, a non-sterile drug manufacturer, revealed a significant concern regarding equipment maintenance. The firm failed to adequately maintain equipment and utensils, specifically hoses used in manufacturing and filling operations, to prevent contamination. This deficiency could compromise the safety, identity, strength, quality, or purity of their drug products.

Company: Fougera Pharmaceuticals, Inc.
Inspection Date: March 26, 2026
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East I
People: Syeda N. Mahazabin (Drug Investigator)
Divek R. Jumani (investigator)

Open in Dashboard

ID · 3378ff57-f3ea-43e3-bacd-abd188d5a398