483
Tulex Pharmaceuticals Inc.Tulex Pharmaceuticals Inc. – FDA 483, Dec 12, 2019
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.
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