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  5. Gasco Industrial - 489096 - 05/30/2019
  1. Warning Letters

CLOSEOUT LETTER

Gasco Industrial MARCS-CMS 489096 —

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

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