CLOSEOUT LETTER
Regal Health Food International, Inc. MARCS-CMS 662089 —
- Delivery Method:
- VIA Electronic Mail
- Reference #:
- WL CMS# 662089 Close-Out Letter
- Product:
- Food & Beverages
- Recipient:
-
Recipient NameMr. Igor Piatigorsky
-
Recipient TitlePresident/Owner
- Regal Health Food International, Inc.
2701 N. Normandy Ave.
Chicago, IL 60707-2227
United States-
- igor@regalsnacks.com
- Issuing Office:
- Division of Human and Animal Food Operations East VI
United States
United States
Dear Mr. Piatigorsky:
The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS #662089 issued on November 29, 2023. 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/
Clarice J. Ahn, Acting Branch Chief
Division of Conventional Foods Enforcement
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program