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

Source: https://www.keypedia.com/records/483/fougera-pharmaceuticals-inc/3378ff57-f3ea-43e3-bacd-abd188d5a398

> FDA 483 for Fougera Pharmaceuticals, Inc. on March 26, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fougera Pharmaceuticals, Inc.
- Inspection Date: 2026-03-26
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

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- [483 - 2022-08-10](https://www.keypedia.com/records/483/fougera-pharmaceuticals-inc/313a4eac-daf4-4b86-b86a-1a2d3ba1847c)
- [483 - 2023-11-17](https://www.keypedia.com/records/483/fougera-pharmaceuticals-inc/edd4f1c5-7ece-4881-ae23-b092b43cf266)

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)
- [investigator](https://www.keypedia.com/people/divek-r-jumani/ba9b28e9-d9b3-4c9f-8532-25f037ff7ce4)

Company: https://www.keypedia.com/companies/fougera-pharmaceuticals-inc/99a927b0-c274-4af7-ab29-2cb4247754c5

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961