• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Haldiman, Keith And Patricia - Closed Out Letter 11/15/10

  

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

Public Health Service
Food and Drug Administration
 Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7133
FAX: (612) 334-4142

November 15, 2010

 

Keith and Patricia Haldiman
N9035 Harvestore Road
Hilbert, Wisconsin 54129

 

Dear Mr. and Mrs. Haldiman:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter MIN 10-17 dated June 30, 2010. 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/


Timothy G. Philips
Compliance Officer
Minneapolis District


TGP/ccl