FDA 483 - Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. - December 21, 2019

An FDA inspection of Meridian Medical Technologies, Inc. identified significant deficiencies across its quality system, primarily impacting the EpiPen autoinjector. The firm failed to adequately establish procedures for corrective and preventive actions, design verification, design validation, and complaint handling. These issues led to concerns about device failures like spontaneous activation and an inability to activate, indicating a lack of robust controls over product design, manufacturing, and post-market surveillance.