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

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.