FDA 483 - AbbVie Inc. - December 15, 2017

An FDA inspection of AbbVie, Inc. in North Chicago, IL, revealed significant deficiencies in the firm's complaint handling procedures, including inadequate investigations for deaths and leaking products, and a failure to procure or test complaint samples. The inspection also cited the firm for not adequately examining reserve samples annually for deterioration and for failing to extend investigations of product failures to other potentially affected batches. Furthermore, written production and process control procedures were not consistently followed, as evidenced by a line clearance event where a half-capsule was found without subsequent corrective actions.