Another warning for endoscope manufacturer after facility inspection in Japan
The warning letter to Olympus Medical Systems Corporation followed previous warning letters issued to the firm and one of its subsidiaries and described numerous violations, including failure to evaluate and report user reports of adverse events.
The FDA on March 15 sent another warning letter to Olympus Medical Systems Corporation, a manufacturer of endoscopes, following a facility inspection in Japan.
The warning letter followed previous warning letters issued to the firm and one of its subsidiaries and described numerous violations of the Federal Food, Drug, and Cosmetic Act at another Olympus manufacturing facility, including failure to evaluate and report user reports of adverse events. Additional violations cited the company's failure to correct and prevent recurrence of quality problems and to verify and validate that its preventive and corrective actions are effective.