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Orthotics & Prosthetics One Inc.

Orthotics & Prosthetics One Inc.

United States

Issuing Office:

United States


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

 Food and Drug Administration
Southwest Region
Kansas City District
8050 Marshall Drive
Suite 205
Lenexa, Kansas 66214-1524

January 29, 2015


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.




Cheryl A. Bigham
District Director
Kansas City District

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