Boule Medical AB

CLOSEOUT LETTER Boule Medical AB MARCS-CMS 559614 — February 26, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Christina Rubenhag Recipient Title Acting Chief Executive Officer Boule Medical AB Domnarvsgatan 4 Spanga 163 53 Stockholms Lan Sweden Issuing Office: Office of In Vitro Diagnostics and Radiological Health United States Dear Ms. Rubenhag: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS # 559614] dated October 2, 2018. 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, /S/ Courtney H. Lias, Ph.D. Deputy Director for Patient Safety and Product Quality Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health CC (US Agent): Deborah A. Herrera Clinical Diagnostic Solutions, Inc. 1800 NW 65th Avenue Plantation, Florida 33313 Content current as of: 03/04/2020 Regulated Product(s) Medical Devices