FDA 483 - Aesculap Inc - October 30, 2019

Aesculap Inc. in Hazelwood, MO, was inspected from October 21-30, 2019, and received a Form FDA 483 with nine observations. The inspection revealed significant deficiencies across its quality system, including inadequate corrective and preventive actions, unvalidated processes, and failures in medical device reporting. These issues indicate a systemic breakdown in ensuring device quality, safety, and regulatory compliance.