Abbvie Biotechnology Ltd. – FDA EIR, Mar 25, 2019

An FDA inspection of Abbvie Biotechnology Ltd. in Barceloneta, PR, occurred from March 12-25, 2019, under Compliance Programs 7356.021A and 7356.002M, focusing on biological drug substances and sterile finished drugs like Humira (Adalimumab). The inspection, which followed up on previous deficiencies, revealed new and recurrent issues. Main violations included ineffective process controls leading to visible extrinsic particles (e.g., cotton, polyester, acrylic fibers) in sterile Humira pre-filled syringes. Critically, the company's validated automatic and manual visual inspection processes failed to detect these fibers before product release. Further issues involved a failure to identify the root causes and implement adequate corrections for recurrent product defects, such as clogged needles and leaks reported by patients. The company also failed to thoroughly evaluate patient claims and investigate numerous consumer complaints (ranging from 200 to 500 per lot) alleging various product defects in distributed lots. These findings fall under the Food, Drug and Cosmetic Act, specifically referencing 21 CFR 211.110(a) concerning process control procedures. Abbvie officials committed to providing a written response to the Form FDA-483 observations within fifteen working days, with the FDA warning that insufficient corrections could result in these observations being classified as violations.