Specification Developer Cited for Complaint Handling

The FDA hit Kirkland, Washington specifications developer Evergreen Orthopedic Research Lab with a Form 483 over its complaint handling procedure.

The agency’s April 8-12 inspection revealed a lack of documentation for an assessment of medical device reporting for a complaint the firm received. The investigator found that the firm’s complaint handling procedure did not require MDR evaluations for all complaints.

The company was unable to produce documentation that justified the lack of an evaluation for medical device reporting.