Medical Energy Cited for Inspection, Other Procedures
FDA auditors noted several problems at Medical Energy’s facility in Pensacola, Fla., including an improperly validated manufacturing process, inadequate design procedures, and other issues.
After conducting an inspection in November 2016, the FDA said the firm did not maintain evidence that its optical fiber laser delivery system process was validated.
The firm also failed to establish device load configurations for use during processing, or to establish a procedure for placement of a dosimeter system. The agency also cited deficiencies in sterilization procedures. For example, the facility did not validate that devices exposed to multiple sterilization cycles functioned properly.