FDA 483 - Augustine Temperature Management, LLC - September 19, 2023

An FDA inspection of Augustine Temperature Management, LLC, a medical device manufacturer in Minneapolis, MN, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, including issues with retroactive CAPA creation and ineffective corrective actions for product failures. Additionally, the company lacked proper documentation for the acceptance or rejection of incoming product components.