Orthotics & Prosthetics One Inc. 29/01/2015

CLOSEOUT LETTER

Orthotics & Prosthetics One Inc. - Close Out Letter 1/29/15

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Department of Health and Human Services
	Food and Drug Administration Southwest Region Kansas City District 8050 Marshall Drive Suite 205 Lenexa, Kansas 66214-1524 913-495-5100

January 29, 2015

UNITED PARCEL SERVICE
SIGNATURE REQUIRED

CMS # 260956

Mr. Dennis E. Clark, President
Orthotics & Prosthetics One Inc.
527 Park Lane, Ste 200
Waterloo, IA 50701

Dear Mr. Clark:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [KAN 2012-04 dated January 9, 2012]. 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/

Cheryl A. Bigham
District Director
Kansas City District

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