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  1. Warning Letters

CLOSEOUT LETTER

Frontier Japan Inc.


Frontier Japan Inc.

 

  

Black HHS-Blue FDA Logo

 

 


 
 New York District
158-15 Liberty Ave
Jamaica, NY 11433

January 31, 2017
 

VIA US POSTAL SERVICE

Mr. Atsushi Nagumo, President
Frontier Japan, Inc.
240 East 27th Street, Apt. 21M
New York, NY 10016
 

Dear Mr.Nagumo:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2016-43 dated September 15, 2016. 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.

We are enclosing a copy of the establishment inspection reports (EIRs) for the inspections conducted at your facility located at 240 East 27th Street, Apt. 21M, New York, NY from July 14th, 2016, 2014 and December 19th, 2016, by the U. S. Food and Drug Administration (FDA). When the Agency concludes that an inspection is “closed”, under 21 C.F.R. 20.64 (d) (3), it will release a copy of the EIRs to the inspected establishment. This procedure is applicable to EIRs for inspections completed on or after April 1, 1997.

The Agency continually works to make its regulatory process and activities more transparent for regulated industry. Releasing these EIRs to you is part of this effort. The copies being provided to you contain the narrative portion of the reports; it may reflect redactions made by the Agency in accordance with the FOIA and 21 C.F.R. Part 20. This, however, does not preclude you from requesting additional information under FOIA.

If there is any question about the released information, feel free to contact me at (518) 453-2314 x1038 or write to: U. S. Food and Drug Administration, New York District, Albany Resident Post, One Winners Circle, Suite 110, Albany, NY 12205.
 

Sincerely,
/S/

W. Martin Rennells
Compliance Officer
FDA - New York District