- Delivery Method:
- VIA Electronic Mail
- Food & Beverages
Recipient NameThomas M. Bross
Recipient TitleChief Executive Officer
- Winter Gardens Quality Foods, Inc.
304 Commerce St.
New Oxford, PA 17350-1723
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
Dear Thomas M. Bross,
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter with CMS #608240, dated August 5, 2020. 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.
Daniel W. Johnson
HAF Division East 2, Philadelphia Office
Office p hone: 215.717.3746
Cc (via email):
Randy F. Pack, Program Division Director, District Director (firstname.lastname@example.org)
Robin M. Rivers, Director, Compliance Branch (Robin.Rivers@fda.hhs.gov)
Martin J. Guardia, Director, Investigations Branch (email@example.com)
Margaret E. DiGennaro, Supervisory Consumer Safety Officer (Margaret.DiGennaro@fda.hhs.gov)