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  5. HNC Products Inc. - 607359 - 02/02/2023
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HNC Products Inc. MARCS-CMS 607359 —

Delivery Method:
UPS Next Day

Recipient Name
Vishnu Potini, MD
Recipient Title
HNC Products Inc.

1619 Commerce Parkway
Bloomington, IL 61704
United States

Issuing Office:
Division of Pharmaceutical Quality Operations III

United States

Dear Dr. Potini:

We received your October 29, 2020; December 2, 2020; January 15, 2021; February 12, 2021; March 19, 2021; April 23, 2021; and February 16, 2022, letters in response to Warning Letter #607359. Your letters have been made a part of the Food and Drug Administration’s (FDA) permanent file for your firm.

The FDA has completed an evaluation of your corrective actions in response to the warning letter. Based on our evaluation, it appears that you have addressed the violations contained in the 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 FDA 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.

Nicholas F. Lyons
Compliance Director
Division of Pharmaceutical Quality Operations III

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