FDA 483 - Novacyl Roussillon - June 27, 2016

Novacyl, an active pharmaceutical manufacturer in Roussillon, France, received two observations during an FDA inspection in June 2016. The firm failed to thoroughly review batch failures related to impurity specifications for an API, and also had issues with equipment maintenance, including leaks and malfunctions, which contributed to product impurity failures. These observations indicate deficiencies in quality control and equipment management practices.