Inspections, Compliance, Enforcement, and Criminal Investigations
Fenwal, Inc. - Close Out Letter 5/7/13
Department of Health and Human Services
|Food and Drug Administration|
|Center for Biologics Evaluation and|
1401 Rockville Pike
Rockville, MD 20852-1448
May 7, 2013
Mr. Robert Baker
Manager, Regulatory Affairs
Lake Zurich, IL 60047
Dear Mr. Baker:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [CBER-12-06 issued June 1, 2012]. 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.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and
Firm Name: Fenwal, Inc.