# FDA 483 - Fougera Pharmaceuticals, Inc. - November 17, 2023

Source: https://www.keypedia.com/records/483/fougera-pharmaceuticals-inc/edd4f1c5-7ece-4881-ae23-b092b43cf266

> FDA 483 for Fougera Pharmaceuticals, Inc. on November 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fougera Pharmaceuticals, Inc.
- Inspection Date: 2023-11-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Fougera Pharmaceuticals, Inc., a non-sterile drug manufacturer in Hicksville, NY, was cited for failing to thoroughly review batch failures. Specifically, the firm did not investigate tube leakage found during the filling of Hydrocortisone Cream, nor did it perform root cause analysis or evaluate preventive actions. This indicates a deficiency in their deviation handling and quality control processes.

## Related Documents

- [483 - 2022-08-10](https://www.keypedia.com/records/483/fougera-pharmaceuticals-inc/313a4eac-daf4-4b86-b86a-1a2d3ba1847c)

## Related Officers

- [Amatul H. Marium](https://www.keypedia.com/people/amatul-h-marium/5db400ce-ffde-4310-82f8-766fd2458a4d)

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