FDA 483 - Abbott Diabetes Care, Inc. - April 21, 2022

Abbott Diabetes Care, Inc. in Alameda, CA, underwent an FDA inspection focusing on its specification developer and complaint file processes. The inspection revealed a significant deficiency in the firm's complaint handling system, specifically regarding the investigation of potential device failures. The firm failed to conduct necessary device history record reviews for complaints where serial numbers were provided but the devices were not returned for analysis.