FDA 483 - Abbvie Biotechnology Ltd.

An FDA inspection of Abbvie Biotechnology LTD in Barceloneta, Puerto Rico, revealed significant deficiencies in quality control systems. The firm failed to adequately investigate and document consumer complaints for its Humira product, and laboratory investigations lacked sufficient supporting evidence. Additionally, procedures for inspecting raw materials and syringes were found to be inadequate, potentially impacting product quality.