Gasco Industrial

CLOSEOUT LETTER Gasco Industrial MARCS-CMS 489096 — May 30, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS NEXT DAY DELIVERY Reference #: 16-SJN-WL-06 Product: Food & Beverages Recipient: Recipient Name Dan Sigman Recipient Title Owner Gasco Industrial Rincon Industrial Park Calle A, Lote 3 Gurabo 00778 Puerto Rico Issuing Office: Center for Food Safety and Applied Nutrition 466 Fernandez Juncos Avenue San Juan 00901 Puerto Rico Dear Mr. Sigman: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to Warning Letter 16-SJN-WL-06, dated February 11, 2016. 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. Kind regards, /S/ Edwin Ramos Director of Compliance Branch OHAFO, Division IV East Content current as of: 05/31/2019 Regulated Product(s) Food & Beverages