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  5. The Sanapac Co., Inc. - 514139 - 04/06/2020
  1. Warning Letters

CLOSEOUT LETTER

The Sanapac Co., Inc. MARCS-CMS 514139 —

Recipient:
Recipient Name
Mrs. Darlene Doble
Recipient Title
President
The Sanapac Co., Inc.

524 Orange Road
Dallas, PA 18612
United States

Issuing Office:
Human & Animal Food Division East II

United States

Dear Mrs. Doble:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 17-PHI-07 issued March 24, 2017. 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 wit 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/
Robin M. Rivers
Compliance Officer
Human and Animal Food East, Division 2

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