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  5. Panther James LLC. dba Drought - 610082 - 11/16/2022
  1. Warning Letters

CLOSEOUT LETTER

Panther James LLC. dba Drought MARCS-CMS 610082 —

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

 
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