FDA 483 - Vortech Pharmaceuticals Ltd - February 09, 2022

Vortech Pharmaceuticals Ltd, a drug manufacturer in Dearborn, MI, was cited for significant deficiencies in its quality control systems. The inspection revealed a lack of process validation for its only drug product, Fatal Plus Solution, and an absence of annual product reviews. Furthermore, the firm failed to conduct microbiological testing for its drug product and lacked scientifically justified water testing procedures.