Best Choice Trading Corp. - Close Out Letter 10/28/14
- Best Choice Trading Corp.
Department of Health and Human Services
|US Food & Drug Administration|
New York District Office
158-15 Liberty Avenue
Jamaica, New York 11433-1034
October 28, 2014
Mr. Lee Fong, President
Best Choice Trading Corp.
146 Stewart Avenue
Brooklyn, NY 11237-1129
Dear Mr. Fang:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2014-25 dated March 20, 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 146 Stewart Avenue, Brooklyn, NY 11237-1129 from February 12 through February 20, 2014 and October 1 through October 2, 2014, 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 EIR 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 this EIR to you is part of this effort. The copy being provided to you contains the narrative portion of the report; 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.
LCDR Catherine M. Beer
FDA - New York District