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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Wannemacher Enterprises - Close Out Letter 1/30/13


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

Public Health Service
Food and Drug Administration
 Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775

January 30, 2013

Greg Wannemacher, President
Wannemacher Enterprises, LLC
d.b.a. Midwest Spray Drying Co.
400 E. Hanthorn Rd.
Lima, OH 45804

Dear Mr. Wannemacher:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 12-310138, dated June 1, 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.



Karen Gale Sego
Compliance Officer