Abaxis Inc

CLOSEOUT LETTER Abaxis Inc MARCS-CMS 558421 — December 17, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Simon Sunderland Recipient Title Board of Directors Officer for Quality Abaxis Inc 3240 Whipple Rd. Union City , CA 94587-1217 United States simon.sunderland@zoetis.com Issuing Office: Office of Medical Device and Radiological Health Operations United States Dear Mr. Sunderland, The Food and Drug Administration has completed an evaluation of your corrective actions in response to a Warning Letter dated 4/12/2019. 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 Compliance Branch Director Office of Medical Devices and Radiological Health Operations Division 3/West cc: Roni Thebo, Director – Global Diagnostics Regulatory Affairs and Pharmacovigilance, roni.m.thebo@zoetis.com Content current as of: 12/17/2021 Regulated Product(s) Medical Devices