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Home » FDA Slaps CellEra for Inadequate Complaint, CAPA and MDR Procedures
FDA Slaps CellEra for Inadequate Complaint, CAPA and MDR Procedures
CellEra has received a Form 483 for not having proper procedures for handling complaints and corrective actions and for other deficiencies observed during an April 11-14 inspection of the company’s Monroe, Ohio, facility.