FDA 483 - LeMaitre Vascular, Inc. - April 16, 2025

Michigan Blood was inspected by the FDA from August 14 to August 24, 2023. The inspection revealed eight observations indicating non-compliance with FDA regulations for blood establishments, specifically 21 CFR Part 606. Key issues included a recurring observation regarding the firm's failure to complete product deviation investigations within the required 30-day timeframe. Platelet testing procedures were not consistently followed, as a platelet unit was transfused without required pH and bacterial contamination testing after an out-of-temperature event. Furthermore, a new Pathogen Reduction Technology system for bacterial detection was inadequately validated, failing to demonstrate equivalency to the previous system. Additional observations noted deficiencies in equipment management, such as an uncalibrated transport thermometer and an unqualified temperature monitoring system. Platelets were not consistently stored at the proper temperature, with insufficient documentation evaluating product suitability after temperature excursions. Quality control records for equipment were not always reviewed, and donor records were found to be incomplete. Lastly, annual competency assessments for several employees had not been performed as required. Michigan Blood is expected to address these observations to ensure compliance with regulatory standards for blood product safety and quality.