FDA 483 - SonoCine Inc. - August 16, 2019

An FDA inspection of Sonotine Inc. in Reno, NV, a medical device manufacturer, revealed significant deficiencies across three observations. The firm failed to adequately control non-conforming products, specifically an unapproved investigational device distributed outside of its clinical study. Additionally, Sonotine Inc. lacked proper supplier management procedures and conducted a clinical investigation without meeting abbreviated requirements for investigational device exemptions, including the absence of IRB involvement and informed consent.