FDA 483 - Augustine Temperature Management, LLC - November 27, 2024

Augustine Temperature Management, LLC, a medical device manufacturer in Minnetonka, MN, was cited for multiple quality system deficiencies during an FDA inspection. Observations included failures to report device corrections and adverse events (MDRs), inadequate finished device acceptance procedures, and deficiencies in both corrective and preventive action and design validation processes. These issues indicate a lack of adherence to established quality system regulations, potentially impacting device safety and effectiveness.