FDA 483 - Laboratoires Urgo - December 14, 2017

An FDA inspection of Laboratoires Urgo, a manufacturer in Chevigny St Sauveur, France, revealed three significant observations. The firm was cited for inadequate process validation, deficiencies in its corrective and preventive action (CAPA) procedures, and insufficient documentation of design outputs prior to release. These issues indicate a need for improved quality system controls.