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  5. Anigan, Inc. - 557163 - 09/26/2019
  1. Warning Letters


Anigan, Inc. MARCS-CMS 557163 —

Medical Devices

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.

Director of Compliance Branch
Office of Medical Device and Radiological Health
Division 3/West

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