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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Willing's Group, Inc - Close Out Letter 10/27/11

  

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

Public Health Service
Food and Drug Administration
 

Central Region
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054 

Telephone (973) 331-4902

October 27, 2011


Ms. Van Chen, President
Willing's Group, Inc.
1936 Olney Avenue Suite A
Cherry Hill, NJ 08003
Dear Ms. Chen:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 11-NWJ-12, dated March 1, 2011. Based on our evaluation, it appears that you have addressed the violations 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/

CAPT Sharon Thoma, PharmD
Acting Director, Compliance Branch
New Jersey District

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