FDA 483 - Azurity Pharmaceuticals, Inc. - March 02, 2023

An FDA inspection of Azurity Pharmaceuticals, Inc. in Wilmington, MA, identified multiple significant deficiencies in quality control and manufacturing. The firm failed to thoroughly investigate consumer complaints regarding lead contamination and product crystallization, as well as the origin of an unknown impurity in Lansoprazole products. Additionally, the inspection revealed inadequate process validation, an insufficient stability program, and unvalidated analytical test methods.