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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Generic Medical Devices, Inc. Close out Letter 7/29/11

   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996 

 

July 29, 2011


VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Robert P. Cummins, Chief Executive Officer
Generic Medical Devices, Inc.
5727 Baker Way NW, Suite 201
Gig Harbor, Washington 98332


Dear Mr. Cummins:
 

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SEA 11-09, dated April 28, 2011. 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/

Charles M. Breen

District Director