Forcemech International LLC

CLOSEOUT LETTER Forcemech International LLC MARCS-CMS 634891 — June 07, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Wenchao (David) Ou Recipient Title President & CEO Forcemech International LLC 4111 Rice Drier Road Ste. #1H Pearland , TX 77581 United States David.Ou@forcemech.com Issuing Office: Office of Medical Device and Radiological Health Division 3 United States Dear Mr. Ou: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (WL #634891) dated September 21, 2022. Based on our evaluation, it appears that you have addressed the violation(s) 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, /S/ Jessica Mu Director, Compliance Branch Office of Medical Device and Radiological Health Operations Division 3 Content current as of: 06/15/2023 Regulated Product(s) Medical Devices