Inspections, Compliance, Enforcement, and Criminal Investigations
CooperVision, Inc. - Close Out Letter 7/5/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
July 5, 2012
Mr. John Weber
6140 Stoneridge Mall Road
Pleasanton, CA 94588
Dear Mr. Weber:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2012-4 issued on December 5, 2011. 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 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.
LCDR Frank Verni, USPHS
FDA - New York District