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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

The Donut Factory, LLC - Close Out Letter 5/1/12

  

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

Public Health Service
Food and Drug Administration
 

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

May 1, 2012

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ms. Vie Sithiphong, Owner
The Donut Factory, LLC
6560 5th A venue South
Seattle, Washington 98108

Dear Ms. Sithiphong:

The Food and Drug Administration has completed our evaluation of your firm's corrective actions in response to Warning Letter SEA 12-12, issued February 8th, 2012. The Agency issues Warning Letters to provide individuals and firms an opportunity to take voluntary and prompt corrective action before an enforcement action is initiated. Based on our evaluation, we have reached a conclusion that your full implementation of these corrective actions has addressed the significant violations contained in the Warning Letter.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure 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 we will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspections or through other means.

Sincerely,

/s/

Charles Breen
Seattle District Director