Tulex Pharmaceuticals Inc.December 12, 2019

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

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Record Details

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.

Company: Tulex Pharmaceuticals Inc.
Inspection Date: December 12, 2019
Product Type: Drugs
Office: New Jersey District Office
Person: Adetutu M. Gidado

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ID · 172155ac-360f-439f-b295-e3c9ea28aa8e