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  5. Elite Laboratories Inc. - Close Out Letter 12/15/17
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CLOSEOUT LETTER

Elite Laboratories Inc.


Recipient:
Elite Laboratories Inc.


United States

Issuing Office:

United States


 

  

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Division of Pharmaceutical Quality Operations I
10 Waterview Blvd, 3rd FL
Parsippany, NJ 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969 

 
 

December 15, 2017

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Nasrat Hakim
President and Chief Executive Officer
Elite Laboratories, Inc.
165 Ludlow Avenue
Northvale, New Jersey 07647

Dear Mr. Hakim:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 16-NWJ-13, dated August 25, 2016. 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 – PHRM1-CB