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  5. Enzymology Research Center, Inc. - 604613 - 03/01/2021
  1. Warning Letters

CLOSEOUT LETTER

Enzymology Research Center, Inc. MARCS-CMS 604613 —

Product:
Drugs
Recipient:
Recipient Name
Troy A. Aupperle
Recipient Title
Owner
Enzymology Research Center, Inc.

332 West Street N.
Miltona, MN 56354-8256
United States

Issuing Office:
Office of Human and Animal Foods - West Division 1

United States

Dear Mr. Aupperle:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated March 26, 2020. 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/
Boun M. Xiong
Compliance Officer, West Division 1 – CB
Office of Human and Animal Food Operations

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