Inspections, Compliance, Enforcement, and Criminal Investigations
S W Seafood, Inc - Close Out Letter 9/4/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
September 4, 2012
Ms. Hau Nguyen, President I Owner
S W Seafood, Inc.
474 - 476 Baltic Street
Brooklyn, NY 11217-2508
Dear Ms. Nguyen:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to Warning Letter NYK-2012-10 issued to you on January 11, 2012. Based on our evaluation of your written responses and follow-up inspection, it appears that you have addressed the violations 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 fm 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.
LCDR Frank Verni, USPHS
FDA- New York District
cc: Mr. Wai K. Chui, Manager