FDA WARNING_LETTER - Zizion Group LLC

The FDA issued a Warning Letter to Zizion Group LLC after reviewing their website, http://yesprpkit.com, which markets the "Yes PRP Kit." The FDA determined the Yes PRP Kit is a medical device intended for preparing platelet-rich plasma for re-administration as a treatment. The firm has not obtained required premarket approval, clearance, or an investigational device exemption for the kit in the United States. Despite this, the website offers the device for sale within the U.S. and misleadingly uses the FDA logo. Consequently, marketing these products violates federal law. The devices are deemed adulterated under section 501(f)(1)(B) of the Act for lacking an approved premarket approval application or investigational device exemption. Furthermore, they are misbranded under section 502(o) of the Act because required notice or information, such as a 510(k) premarket notification, was not provided to the FDA. Zizion Group LLC must take prompt corrective action and notify the FDA in writing within fifteen working days, detailing steps taken or reasons for delay. Failure to comply may lead to regulatory actions including seizure, injunction, civil money penalties, and may impact federal contract awards.