FDA 483 - CellEra LLC - July 08, 2021

CellEra LLC, a medical device specification developer in Monroe, OH, was inspected by the FDA from June 16 to July 8, 2021. The inspection revealed numerous significant quality system deficiencies, many of which were repeat observations from a previous inspection. The firm lacks established procedures for critical areas such as corrective and preventive actions, design control, purchasing controls, incoming product acceptance, complaint handling, MDR reporting, document control, and environmental controls for sterile product storage.