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  5. Kaltec Food Packaging Inc. - 553493 - 07/18/2019
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CLOSEOUT LETTER

Kaltec Food Packaging Inc. MARCS-CMS 553493 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Harriet L. Mascara
Recipient Title
CEO
Kaltec Food Packaging Inc.

36-40 Center St.
Port Jervis, NY 12771
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

158-15 Liberty Avenue
Jamaica, NY 11433
United States

Dear Ms. Mascara:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 553493, issued on June 8, 2018. 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/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1

 
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