FDA WARNING_LETTER - Olympus Corporation of the Americas - April 24, 2015

The FDA conducted inspections at Olympus Medical Systems Corporation facilities in Japan and Olympus Corporation of the Americas facilities in the U.S. during March and April 2015, identifying significant violations related to Medical Device Reporting (MDR) for endoscopes and accessories, specifically the duodenovideoscope Olympus TJF Type Q-180V. The device was deemed misbranded under section 502(t)(2) of the Act due to the firm's failure to furnish required information under section 519 and 21 CFR Part 803. Key deficiencies included the failure to report information suggesting a device caused or contributed to a death or serious injury within 30 calendar days, as required by 21 CFR 803.50(a)(1). An example cited was the delayed reporting of multiple Pseudomonas aeruginosa infections linked to device use. Additionally, the firm failed to adequately develop, maintain, and implement written MDR procedures, as mandated by 21 CFR 803.17(a)(3), specifically lacking internal systems for timely transmission of complete reports and instructions for the FDA 3500A form. The firm's response to the FDA 483 was deemed inadequate due to a lack of supporting documentation and evidence of implementation for corrective actions. Olympus is required to notify the FDA within fifteen business days with specific, documented corrective actions addressing systemic problems, including a timetable for any long-term activities. The FDA noted that these violations might indicate broader issues within the firm's manufacturing and quality management systems, and federal agencies may consider this information when awarding contracts.