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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Simplydelicious - Close Out Letter 1/19/11

  

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

Public Health Service
Food and Drug Administration
 

Southwest Region
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100

 

January 19, 2011


Beryl Stafford, Owner
Simplydelicious LLC dba Bobo's Oat Cakes
4725 Nautilus Court South
Unit 1
Boulder, CO 80301

Dear Ms. Stafford:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter DEN-10-09-WL, dated March 23, 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/


Karen S. Kreuzer
Acting Denver District Director