FDA 483 - CellEra LLC - May 30, 2019

Cellkera LLC, a medical device manufacturer in Monroe, OH, was inspected by the FDA from May 28-30, 2019. The inspection revealed significant deficiencies across its quality system, including a lack of established procedures for purchasing controls, acceptance activities, corrective and preventive actions, complaint handling, MDR reporting, design control, and environmental controls for sterile product storage. These issues indicate a broad failure to maintain adequate quality system processes for medical device manufacturing.