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CLOSEOUT LETTER

Koryeo International Corp. Mar 24, 2015

Koryeo International Corp. - Close Out Letter 3/24/15


Koryeo International Corp.

  

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

 
 US Food & Drug Administration
New York District Office
158-15 Liberty Avenue
Jamaica, New York 11433-1034

 

March 24, 2015


Mr. Steve IIong, President
Koryeo International Corp.
200 Stewart A venue
Brooklyn, NY 11237-1131


Dear Mr. Hong:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2014-58 dated September 15, 2014. 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 200 Stewart Avenue, Brooklyn, NY 11237-1131 from August 1 through August 6, 2014 and March 20, 2015, 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 x1015 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/

LCDR Catherine M. Beer
Compliance Officer
FDA- New York District