# FDA 483 - Fougera Pharmaceuticals, Inc. - August 10, 2022

Source: https://www.keypedia.com/records/483/fougera-pharmaceuticals-inc/313a4eac-daf4-4b86-b86a-1a2d3ba1847c

> FDA 483 for Fougera Pharmaceuticals, Inc. on August 10, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fougera Pharmaceuticals, Inc.
- Inspection Date: 2022-08-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Fougera Pharmaceuticals, Inc. in Hicksville, NY, received a Form 483 with two observations related to manufacturing controls. The inspection revealed deficiencies in equipment cleaning validation and a lack of adequate written procedures for production and process controls. These issues included an incomplete cleaning validation study for a bottle filler and problems with process validation and operator actions during line stoppages, indicating potential risks to drug product quality.

## Related Documents

- [483 - 2023-11-17](https://www.keypedia.com/records/483/fougera-pharmaceuticals-inc/edd4f1c5-7ece-4881-ae23-b092b43cf266)

## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [Amatul H. Marium](https://www.keypedia.com/people/amatul-h-marium/5db400ce-ffde-4310-82f8-766fd2458a4d)
- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

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