Vinill Inc.

CLOSEOUT LETTER Vinill Inc. MARCS-CMS 564925 — February 28, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United Parcel Service Recipient: Recipient Name Leonid Kats Recipient Title Owner Vinill Inc. 4801 2nd Ave Brooklyn , NY 11232-4220 United States Issuing Office: Center for Food Safety and Applied Nutrition United States Dear Mr. Kats: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [CMS 564925, September 21, 2018]. 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 sustinability 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 implemnting 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 andy furture regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /s/ CDR Catherine M. Beer Director of Compliance Office of Human and Animal Food Operations East - Division 1 Content current as of: 03/11/2019