1st Phorm LLC

CLOSEOUT LETTER 1st Phorm LLC MARCS-CMS 613715 — February 08, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 02/15/2022 Regulated Product(s) Dietary Supplements Food & Beverages