FDA 483 - Abbvie Biotechnology Ltd. - March 25, 2019

Abbvie Biotechnology Ltd. in Barceloneta, PR, a manufacturer of biologic drug substances and products, received a Form FDA 483 following an inspection from March 12-25, 2019. The inspection revealed significant deficiencies in process controls, complaint investigations, and quality oversight related to their Humira (adalimumab) pre-filled syringes, including issues with visible particles, clogged needles, and syringe leaks. The firm failed to adequately investigate and address these recurring product defects and consumer complaints.