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CLOSEOUT LETTER

1st Phorm LLC MARCS-CMS 613715 —

Delivery Method:
VIA UPS
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Andrew Frisella
Recipient Title
CEO
1st Phorm LLC

2091 Fenton Logistics Park Blvd
Fenton, MO 63026
United States

Issuing Office:
Office of Human and Animal Food West Division II

United States

Dear Mr. Andrew Frisella,

The Food and Drug Administration has completed an evaluation of 1st Phorm LLC corrective actions in response to our Warning Letter (CMS case #: 613715) on July 29, 2021. Based on our evaluation, it appears that you have addressed the violation(s) 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/
LaTonya M. Mitchell, Ph.D.
District Director
FDA Kansas City District
Program Division Director
Office Of Human and Animal Foods-West Division 2

 
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