CLOSEOUT LETTER
Japanese Specialty Food Distributors Ltd, Co. Mar 11, 2015
Japanese Specialty Food Distributors Ltd, Co. - Close Out Letter 3/11/15
- Japanese Specialty Food Distributors Ltd, Co.
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| Food and Drug Administration New England District Office One Montvale Avenue, 4th floor Stoneham, MA 02180 Phone 781.587.7500 Fax 781.587.7556 |
Department of Health and Human Services
March 11, 2015
Mr. Jun Y. Kim, President
Japanese Specialty Food Distributors Ltd, Co.
2 Sand Cut Rd., Ste 7
Brookfield, CT 06804
Dear Mr. Kim:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS 437659, August 29, 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.
Sincerely,
/S/
Amber Wardwell
Director Compliance Branch
New England District