FDA 483 - Abbott Point of Care Canada Limited - May 16, 2022

An FDA inspection of Abbott Point of Care Canada Limited, a contract manufacturer in Nepean, Ontario, Canada, identified deficiencies related to design controls and production and processing. The observations included issues with creating and approving master records, general design controls, device specifications, and managing production and processing changes. These findings indicate a need for improved adherence to quality system requirements for medical device manufacturing.