Orchid Orthopedic Solutions, LLC

CLOSEOUT LETTER Orchid Orthopedic Solutions, LLC MARCS-CMS 580112 — May 13, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Medical Devices Recipient: Recipient Name Nathan A. Folkert Recipient Title Chief Executive Officer Orchid Orthopedic Solutions, LLC CEP Bio-Coat, LLC 1489 Cedar Street Holt , MI 48842 United States Nate.Folkert@orchid-ortho.com Issuing Office: Center for Devices and Radiological Health United States Dear Mr. Folkert: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 580112) issued on May 13, 2019, at CEP Bio-Coat/Orchid Orthopedic Solutions, LLC, located at 23149 Commerce Drive, Farmington Hills, MI,, FEI 3011277306. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely yours, /S/ Gina M. Brackett Director, Compliance Branch Office of Medical Device & Radiological Health Division-1 East Office of Regulatory Affairs U.S. Food and Drug Administration Content current as of: 01/24/2023 Regulated Product(s) Medical Devices