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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Manolo and Son, LLC - Close Out Letter 10/26/11

  

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

Public Health Service
Food and Drug Administration
 

Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
Fax: (410) 779-5705 

FEI: 3005719169


October 26, 2011


Certified Mail
Return Receipt Requested

Ms. Joan A. Ribadulla, Co-Owner
Manolo and Son, LLC
1230-B N. Henry Street
Alexandria, VA 22314

Dear Ms. Ribadulla:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS 180377 dated May 16, 2011. Based on our evaluation, it appears that you have adequately 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/

Cherlita Honeycutt
Compliance Officer
Baltimore District