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  5. Standard Textile Co., Inc. - 06/24/2014
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Standard Textile Co., Inc.

Standard Textile Co., Inc.

United States

Issuing Office:

United States


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

 Food and Drug Administration
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
             FAX: (513) 679-2761


June 24, 2014

Mr. Gary L. Heiman, President/CEO
Standard Textile Co., Inc.
1 Knollcrest Drive
Cincinnati, OH 45237

Dear Mr. Heiman:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CIN-13-394883-21 dated May 07, 2013. 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.




Toniette K. Williams
Director, Compliance Branch

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