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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

American Quality Manufacturing, Inc. - Close Out Letter 1/31/12

  

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

Public Health Service
Food and Drug Administration
 Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770

January 31, 2012

 

Mr. David L. McConnell
President
American Quality Manufacturing, Inc.
310 Shearer Blvd, Suite "A"
Cocoa, FL 32922

Dear Mr. McConnell:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [FLA-11-37]. 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/

Emma Singleton
Florida District Director