FDA 483 - CellEra LLC - April 14, 2022

CellEra LLC, an initial importer in Monroe, OH, was inspected by the FDA from April 11-14, 2022. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning the lack of established procedures for complaint handling, acceptance activities, corrective and preventive actions (CAPA), and Medical Device Reporting (MDR). These issues indicate a systemic failure to implement fundamental quality control processes.