Anigan, Inc.

CLOSEOUT LETTER Anigan, Inc. MARCS-CMS 557163 — September 26, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Ai Chen (Sarah) Teo Recipient Title President and General Manager Anigan, Inc. 6550 Bennington Way San Ramon , CA 94582-3902 United States Issuing Office: Office of Medical Device and Radiological Health Operations (Division 3W) 19701 Fairchild Irvine , CA 92612 United States Dear Ms. Teo: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [WL CMS 557163 dated July 25, 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/ Director of Compliance Branch Office of Medical Device and Radiological Health Division 3/West Content current as of: 09/30/2019 Regulated Product(s) Medical Devices