# FDA 483 - Tulex Pharmaceuticals Inc. - December 12, 2019

Source: https://www.globalkeysolutions.net/records/483/tulex-pharmaceuticals-inc/172155ac-360f-439f-b295-e3c9ea28aa8e

> FDA 483 for Tulex Pharmaceuticals Inc. on December 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tulex Pharmaceuticals Inc.
- Inspection Date: 2019-12-12
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Tulex Pharmaceuticals Inc, a pharmaceutical manufacturer in Cranbury, NJ, was cited during an FDA inspection for a critical equipment qualification failure. The firm had not qualified a stainless-steel mixing tank essential for commercial manufacturing, leading to concerns about its consistent and reliable operation. This observation indicates a significant lapse in quality assurance for their production processes.

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## Related Officers

- [Adetutu M. Gidado](https://www.globalkeysolutions.net/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

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

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