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  5. SuperValue, Inc. - 507321 - 02/17/2017
  1. Warning Letters

CLOSEOUT LETTER

SuperValue, Inc. MARCS-CMS 507321 —

Delivery Method:
Certified Mail
Recipient:
Recipient Name
Ms. Beth Kroutch
Recipient Title
General Manager
SuperValue, Inc.

500 South Muddy Creek Road
Denver, PA 17517
United States

Issuing Office:
Philadelphia District Office

2nd and Chestnut Streets
Room 900
Philadelphia, PA 19106
United States

215-597-4390

Dear Ms. Kroutch:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 16-PH-14 issued September 20, 2016. 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/
Steven L. Carter
Director, Compliance Branch
Philadelphia District Office

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