FDA 483 - Allergan Industrie SAS - January 29, 2015

An FDA inspection of Allergan Industrie SAS in Pringy, France, a medical device manufacturer, revealed significant deficiencies in its corrective and preventive action (CAPA) procedures. The firm failed to establish adequate procedures for identifying necessary actions to correct and prevent recurrence of nonconforming products. Additionally, procedures for verifying or validating the effectiveness of corrective and preventive actions were not adequately established, leading to ongoing product issues.