FDA 483 - Abbott Point of Care Canada Limited - May 19, 2022

The U.S. Food and Drug Administration (FDA) conducted an inspection of Abbott Point of Care Canada Limited, a contract manufacturer based in Nepean, Ontario, Canada, from May 16 to May 19, 2022. Following this inspection, the FDA issued a Form 483, detailing observations of conditions that indicate potential violations of the agency's quality system regulations for medical devices. The primary issues identified during the inspection pertained to the company's design controls and production and processing systems. Specific observations included shortcomings in the creation and approval of master manufacturing records, general deficiencies in the implementation of design control procedures, and inadequate adherence to established device specifications during the manufacturing process. Furthermore, the FDA noted concerns regarding the control and documentation of production and processing changes. These observations highlight areas where Abbott Point of Care Canada Limited needs to strengthen its adherence to the U.S. regulatory framework for medical device quality systems. The company is required to thoroughly review these findings and implement appropriate corrective actions to resolve the identified issues and ensure full compliance with regulatory requirements. The FDA emphasizes the importance of robust internal audits to proactively identify and rectify quality system deviations.