U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Ideal Implant Incorporated - 606103 - 07/15/2021
  1. Warning Letters

CLOSEOUT LETTER

Ideal Implant Incorporated MARCS-CMS 606103 —

Delivery Method:
VIA Electronic Mail
Product:
Medical Devices

Recipient:
Recipient Name
Robert S. Hamas, MD
Recipient Title
CEO and President
Ideal Implant Incorporated

14881 Quorum Drive
Suite 925
Dallas, TX 75254
United States

rhamas@idealimplant.com
Issuing Office:
Center for Devices and Radiological Health

United States


Dear Mr. Hamas:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated May 14, 2020. 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,
Director, Compliance Branch
Office of Medical Devices and
Radiological Health, Division III

 
Back to Top