Panther James LLC. dba Drought

CLOSEOUT LETTER Panther James LLC. dba Drought MARCS-CMS 610082 — November 16, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: FY21-HAFE6-WL-01 Product: Food & Beverages Recipient: Recipient Name Caitlin G. James Recipient Title CEO Panther James LLC. dba Drought 44696 Morley Dr. Clinton Township , MI 48036 United States Issuing Office: Division of Human and Animal Food Operations East VI United States Caitlin G. James, CEO Jennifer E. James, COO Jessica M. James, Chief Business Development Officer Julie James, Chief Marketing Officer Dear Mss. James, The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (FY21-HAFE6-WL-01, issued March 5, 2021). 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/ Kelli Wilkinson Director of Compliance Office of Human and Animal Food Division East 6 Content current as of: 11/18/2022 Regulated Product(s) Food & Beverages