FDA WARNING_LETTER - Dr. Ashley Minas

This FDA Warning Letter, dated May 29, 2015, was issued to Minasian Medical Centre for illegally marketing Interfall Hydrogel and Teosyal products in the United States without the required marketing clearance or approval. The FDA determined these products, advertised as dermal fillers and aesthetic medicine on www.consultdrminas.com, are medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act. The firm's failure to obtain approved applications for premarket approval (PMA) under section 515(a) or an investigational device exemption (IDE) under section 520(g) renders the devices adulterated under section 501(f)(1)(B) of the Act. Furthermore, the devices are misbranded under section 502(o) because the firm did not provide the mandatory 510(k) notification prior to commercial distribution. Due to these serious violations, the Interfall Hydrogel and Teosyal products are subject to refusal of admission into the U.S. Minasian Medical Centre must provide a written response within fifteen business days detailing specific corrective actions, plans to prevent recurrence, and a timetable for implementation, including supporting documentation. The response should comprehensively address all identified violations.