Vaccaro's Italian Pastry Shop, Inc.

CLOSEOUT LETTER Vaccaro's Italian Pastry Shop, Inc. MARCS-CMS 577001 — January 04, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Food & Beverages Recipient: Recipient Name Ms. Maria R. Vaccaro Recipient Title Vice President Vaccaro's Italian Pastry Shop, Inc. 3705 E. Baltimore Street Baltimore , MD 21224-1509 United States cookies@vaccarospastry.com Issuing Office: Division of Human and Animal Food Operations East II United States Dear Ms. Vaccaro, The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 577001, dated March 24, 2019. 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/ Jessica D. Weber Compliance Officer Baltimore District Office Human & Animal Food East, Division 2 Office of Regulatory Affairs U.S. Food and Drug Administration T: 410-779-5407 M: 443-280-1276 jessica.weber@fda.hhs.gov Cc (via email): Randy F. Pack, Program Division Director, District Director (randy.pack@fda.hhs.gov) William Murray, State Liaison (william.murray@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) Cornelius Brown III, Supervisory Consumer Safety Officer (cornelius.brown1@fda.hhs.gov) Content current as of: 01/14/2022 Regulated Product(s) Food & Beverages