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Omega Engineering Inc. MARCS-CMS 613560 —

Medical Devices

Recipient Name
Christine Riggs
Recipient Title
In-House Counsel
Omega Engineering Inc.

800 Connecticut Avenue
Suite 5N01
Norwalk, CT 06854
United States

Issuing Office:
Center for Devices and Radiological Health

United States

Dear Christine Riggs:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 613560, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter.

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 in the future.

Sincerely yours,
Courtney H. Lias, Ph.D.
Director Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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