Abbott

CLOSEOUT LETTER Abbott MARCS-CMS 519686 — April 28, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Randel Woodgrift Recipient Title Senior Vice President Abbott 15900 Valley View Court Sylmar , CA 91342 United States mailto:Randel.woodgrift@abbott.com Issuing Office: Medical Device & Radiological Health Operations Division 3/West United States Dear Mr. Woodgrift: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #519686, April 12, 2017). Based on our evaluation, it appears that your firm has 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/ Jessica Mu, Director of Compliance Medical Device & Radiological Health Operations Division 3/West Content current as of: 05/07/2020