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.
The facility was also cited for poor handling of complaints it received in 2017. A summary of the year’s complaints indicated it received 47 contamination, 11 shipping, five performance and nine complaints related to other issues. But managers could only locate 23 complaint records for 2017.
In addition, three production employees had no documented training record and annual GMP training was not documented for any employees.
The investigator also found that quality audits were not adequate to determine whether the firm’s quality system activities complied with procedures. Specifically, the firm did not conduct quality audits to the frequency or scope required in its quality system internal audit program. In 2016 and 2017, only a single audit activity was performed.