FDA WARNING_LETTER - Olympus Medical Systems Corporation - September 09, 2022

On December 12, 2022, the FDA issued a Warning Letter to Tomohisa Sakurai following an inspection of their Hachioji-shi, Tokyo, Japan facility from September 6-9, 2022. The firm manufactures gastrointestinal and surgical endoscopes, classified as medical devices.

The inspection revealed the firm's devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), due to failure to furnish material or information required by section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR).

Specifically, the firm failed to submit MDRs within 30 calendar days for device malfunctions that would likely cause or contribute to death or serious injury if they recurred, as required by 21 CFR 803.50(a)(2). Examples include complaints (b)(4) (MDR# 8010047-2021-02641), (b)(4) (MDR# 8010047-2021-07387), (b)(4) (MDR# 8010047-20