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CLOSEOUT LETTER

Gentell, Inc


Gentell, Inc

 

  

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Philadelphia District Office
900 U.S. Customhouse
200 Chestnut Street
Philadelphia, PA 19106
Telephone: (215) 597-4390
FAX: (215) 597-8212 

March 16, 2017

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

David Navazio, Executive Vice President
2701 Bartram Rd.
Bristol, PA 19007

Dear Mr. Navazio:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 15-PHI-21, dated October 5, 2015. Based on our evaluation, it appears that you have addressed the violation(s) contained in the 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 you firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and it 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/

Yvette Johnson
Compliance Officer
Philadelphia District Office