FDA WARNING_LETTER - Sopro Comeg Gmbh - May 08, 2014

On February 23, 2015, the FDA issued a Warning Letter to Sopro-Comeg GmbH following an inspection from May 5-8, 2014, in Tuttlingen, Germany. The inspection revealed that the ULYSS Multi View Sinuscope, a medical device, was adulterated and misbranded.

The device was deemed adulterated under section 501(f)(1)(b) of the Act because the firm lacked an approved Premarket Approval (PMA) application or an approved Investigational Device Exemption (IDE). It was also misbranded under section 502(o) for failure to submit a 510(k) premarket notification. Additionally, the device was misbranded under Section 502(t)(2) due to the firm's failure to provide required material or information under Section 519 and 21 CFR Part 803 (Medical Device Reporting). A significant deviation noted was the failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. While the firm submitted an updated MDR procedure in response to the FDA Form 483, its adequacy is still under review.

As a result of these violations, the ULYSS Multi View Sinuscope is subject to refusal of admission into the United States under section 801(a) of the Act,