Primus Corporation dba Trinity Biotech

CLOSEOUT LETTER Primus Corporation dba Trinity Biotech MARCS-CMS 607698 — December 22, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Ronan O'Caoimh Recipient Title President/CEO Primus Corporation dba Trinity Biotech Southern Cross Business Park I D A Boghall Road Bray Co. Wicklow Ireland ronan.ocaoimh@trinitybiotech.com josh.wcarsC_i,Arinitybiotech.com Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Mr. O'Caoimh: The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter (CMS # 607698) issued on August 11, 2020. Based, on our evaluation, it appears that you have addressed the violations contained in the 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/ Melissa Michurski, Director Compliance Branch Office of Medical Device and Radiological Health Division 2 Content current as of: 04/17/2024 Regulated Product(s) Medical Devices