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  5. Polette Cyril (Caribbean Variety Store) - Close Out Letter 9/2/16
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CLOSEOUT LETTER

Polette Cyril (Caribbean Variety Store)


Polette Cyril (Caribbean Variety Store)

  

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

 
 New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433

September 2, 2016

Ms, Pollete Cyril, President/Owner
Caribbean Variety Store
1483 Westchester Avenue
Bronx NY, 10472

Dear Ms. Cyril:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, NYK-2016-21, issued on January 27, 2016. Based on our evaluation of your written responses and follow-up inspection, 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/

CDR Frank Verni, RPh
Compliance Officer
FDA - New York District