The FDA has sent a warning letter to Olympus, alerting the company to non-conformity issues at a Japanese facility used to manufacture endoscopes and endoscope accessories including, Single-Use Distal Covers for Duodenoscopes and Single-Use Suction Valve Accessories for Bronchoscopes.
The agency said its latest inspection of the facility revealed that these devices did not meet current good manufacturing practice requirements in terms of the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation.
The FDA specifically called out Olympus for "failure to adequately establish and maintain procedures for implementing corrective and preventive action, including analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems."
Olympus has received numerous complaints regarding its distal end covers including packaging defects.
The agency has requested Olympus respond with its plan for corrective actions.