# FDA 483 - Tulex Pharmaceuticals Inc. - March 24, 2025

Source: https://www.keypedia.com/records/483/tulex-pharmaceuticals-inc/a13a486c-928d-431f-847a-5d4f12d53869

> FDA 483 for Tulex Pharmaceuticals Inc. on March 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tulex Pharmaceuticals Inc.
- Inspection Date: 2025-03-24
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Tulex Pharmaceuticals Inc. in Cranbury, NJ, a manufacturer of finished drug products, received a Form 483 for significant deficiencies in their quality system. The inspection revealed failures to thoroughly investigate stability failures of finished drug products and inadequate corrective and preventive action procedures. Additionally, the firm lacked scientifically sound laboratory controls and testing procedures for organic impurity analysis.

## Related Documents

- [483 - 2019-12-12](https://www.keypedia.com/records/483/tulex-pharmaceuticals-inc/172155ac-360f-439f-b295-e3c9ea28aa8e)

## Related Officers

- [Suchan Kim](https://www.keypedia.com/people/suchan-kim/1acf9a36-036f-48a8-a8a4-caa290830e37)
- [James R. Birkenstamm](https://www.keypedia.com/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)

Company: https://www.keypedia.com/companies/tulex-pharmaceuticals-inc/e9839d9b-b973-49c3-916a-4ca187d606dd

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248