Tennessee IVD Firm Warned on Multiple Quality Issues

A Memphis, Tenn., diagnostics firm has been slapped with an FDA warning letter after an inspection found multiple quality and complaint-handling problems throughout the facility. Inspectors found poor documentation of Edge Biologicals’ corrective and preventive action (CAPA) activities. For example, one CAPA was initiated after agar plates were damaged during shipment.
Devices & Diagnostics Letter