Inspections, Compliance, Enforcement, and Criminal Investigations
Flagship Niagara League Inc. - Close Out Letter 7/12/11
| Public Health Service Food and Drug Administration |
PHILADELPHIA DISTRICT |
Department of Health and Human ServicesCERTIFIED MAIL
RETURN RECEIPT REQUESTED
July 12, 2011
Wesley W. Heerseen, Jr., Master
Flagship Niagara League, Inc.
150 E. Front Street
Erie, PA 16507-1594
Dear Mr. Heerseen:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 10-PHI-10 issued August 25, 2010. Based on our evaluation, 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 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/
Steven L. Carter
Director, Compliance Branch
Philadelphia District Office
