Pharmaganics LLC – 614576 – 01/12/2022

Pharmaganics LLC – 614576 – 01/12/2022
Anonymous (not verified)
Tue, 01/18/2022 – 09:26

Company Name
Short Title
Pharmaganics LLC

Dear Mr. Redmond:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #614576, issued September 7, 2021. Based on our evaluation, it appears 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 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/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

Tue, 01/18/2022 – 09:47
Review Date
Mon, 12/18/2023 – 00:00
Source Organization
Recipient Name
Tom Redmond III
Recipient Title
CEO
Last Reviewed Date
Sun, 12/18/2022 – 00:00
Site Structure
Letter Issue Date
January 12, 2022
Issuing Office Building Name
Center for Food Safety and Applied Nutrition (CFSAN)
Next Review Date
1 Year
Detailed Description
Unapproved New Drugs/Misbranded

info@diabetesdoctor.com

MARCS CMS ID
Bulk Approved
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Address

United States

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Regulated Product*
Sender Address

United States

Recipient Address

8475 Parley Lake Rd
Waconia, MN 55387
United States

Language
Address

United States

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