Winter Gardens Quality Foods, Inc.

CLOSEOUT LETTER Winter Gardens Quality Foods, Inc. MARCS-CMS 608240 — October 01, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Food & Beverages Recipient: Recipient Name Thomas M. Bross Recipient Title Chief Executive Officer Winter Gardens Quality Foods, Inc. 304 Commerce St. New Oxford , PA 17350-1723 United States tbross4@wintergardens.com Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States 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. Sincerely, /S/ Daniel W. Johnson Compliance Officer HAF Division East 2, Philadelphia Office Office p hone: 215.717.3746 e-mail: Daniel.Johnson@fda.hhs.gov Cc (via email): Randy F. Pack, Program Division Director, District Director (randy.pack@fda.hhs.gov) Robin M. Rivers, Director, Compliance Branch (Robin.Rivers@fda.hhs.gov) Martin J. Guardia, Director, Investigations Branch (martin.guardia@fda.hhs.gov) Margaret E. DiGennaro, Supervisory Consumer Safety Officer (Margaret.DiGennaro@fda.hhs.gov) Content current as of: 10/08/2021 Regulated Product(s) Food & Beverages