Allergan Sales, LLC – FDA 483, Jul 10, 2015

An FDA inspection of Allergan Sales, LLC in Waco, TX, revealed significant deficiencies in their quality system, particularly concerning the thoroughness and timeliness of investigations into product complaints and environmental control issues. The firm also failed to follow aseptic cleaning procedures for sterile ophthalmic product filling lines. These issues indicate a lack of robust quality oversight and potential risks to product quality and patient safety.