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U.S. Department of Health and Human Services

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Enforcement Actions

Extremity Medical LLC - Close Out Letter 11/26/2012

  

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

Public Health Service
Food and Drug Administration
 Central Region
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054

Telephone (973) 331-4900

 

November 26, 2012

Jamy R. Gannoe
President
Extremity Medical, LLC
300 Interpace Pkwy
Ste 410, Bldg A
Parsippany, NJ 07054-1148


Dear Mr. Gannoe:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (12-NWJ-14), issued on February 24, 2012. 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.

The 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. Joseph F. MgGinnis
Director Compliance Branch
New Jersey District