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CLOSEOUT LETTER

Medical Specialties of California


Medical Specialties of California

 

  

Black HHS-Blue FDA Logo

 

 

 
10903 New Hampshire Avenue
Silver Spring, MD 20993 

APRIL 25, 2017

Mr. Frank Fronda
Director
Medical Specialties of California UK, Limited
Tara House, 274 Hither Green Lane
London SE13 6TT
United Kingdom

Dear Mr. Fronda:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, CMS #495212, dated August 15, 2016. 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/

CAPT Raquel Peat, PhD, MPH, USPHS
Director
Division of Premarket and
    Labeling Compliance
Office of Compliance
Center for Devices and
    Radiological Health