Edge Biologicals was hit with a Form 483 for violations at its Memphis, Tennessee facility, including inadequate environmental monitoring, poor complaint handling and incomplete recordkeeping observed during a March inspection.
The FDA investigator noted the drugmaker failed to establish requirements for multiple environmental monitoring activities in aseptic filling operation areas. For example, it did not monitor the air or document temperature or humidity and it lacked methods for monitoring personnel and gowning processes.
The facility’s cleaning processes for controlled environment areas (a conveyor line, a high efficiency particulate air bench and a large conveyor room), did not have validated cleaning systems for aseptic processing. The firm also failed to validate sterilization of tubing sets used in aseptic fill operations for culture media devices.