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CLOSEOUT LETTER

Organics Corporation of America DBA Ambix Laboratories Apr 22, 2014

Organics Corporation of America dba Ambix Laboratories - Close Out Letter 4/22/14


Organics Corporation of America DBA Ambix Laboratories

  

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

 
 Food and Drug Administration
New Jersey District Office
Central Region
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969

 

April 22, 2014


Organics Corporation of America (dba Ambix Laboratories)
Attn: Mr. Alvin J. Goren, President
55 West End Road
Totowa, New Jersey 07512-1405


Dear Mr. Goren:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (13-NWJ-05), dated 02/22/2013. Based on our evaluation, it appears that you have 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/

Capt. Joseph McGinnis
Director Compliance Branch
New Jersey District