FDA 483 - Probed Medical Technologies, Inc. - August 11, 2022

Probed Medical Technologies, Inc. in Abbotsford was inspected by the FDA from August 8-11, 2022. The inspection revealed significant deficiencies in the firm's quality system, including inadequate corrective and preventive action procedures, a lack of established complaint handling processes, and insufficient control over production processes. These issues indicate a moderate level of non-compliance with regulatory requirements for medical device manufacturing.