- Delivery Method:
- VIA EMAIL WITH READ RECEIPT
- Reference #:
- Food & Beverages
Recipient NameCaitlin G. James
- Panther James LLC. dba Drought
44696 Morley Dr.
Clinton Township, MI 48036
- Issuing Office:
- Division of Human and Animal Food Operations East VI
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.
Director of Compliance
Office of Human and Animal Food
Division East 6