FDA 483 - Tubilux Pharma Spa - December 02, 2019

Tubilux Pharma Spa in Pomezia, Italy, received a Form 483 with four observations during an FDA inspection from December 2-10, 2019. The inspection revealed significant issues across quality systems, including inadequate review of biological indicator data for sterile products, deficient complaint investigations for packaging malfunctions, and failures within the quality control unit regarding viscosity test evaluations and supplier controls. These findings indicate a moderate level of concern regarding the firm's adherence to cGMPs for drug manufacturing.