FDA 483 - Magellan Diagnostics, Inc. - October 21, 2019

An FDA inspection of Magellan Diagnostics, Inc. in North Billerica, MA, revealed five significant observations, many of which were repeat findings. The firm demonstrated inadequate procedures for corrective and preventive actions, complaint handling, and medical device reporting. Additionally, deficiencies were noted in risk analysis and the maintenance of device master records for their LeadCare product line.