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  5. Golden Lab LLC - 625783 - 03/22/2024
  1. Warning Letters

CLOSEOUT LETTER

Golden Lab LLC MARCS-CMS 625783 —

Delivery Method:
VIA Electronic Mail
Reference #:
24-HAFE4-WLCOL-05
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Dr. Howard J. Loff, M.D.
Recipient Title
Owner and CEO
Golden Lab LLC

2375 Saint Johns Bluff Rd S Ste 310
Jacksonville, FL 32246-2335
United States

Hloffmd@doctorsoptimalformula.com
Issuing Office:
Office of Human and Animal Food Operations East Division IV

United States

Secondary Issuing Offices

United States

Dear Dr. Loff:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 22-HAFE4-WL-05 dated May 26, 2022. 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.


Kind regards,
/S/
Pearl E. Lopina
Director of Compliance Branch
OHAFO, Division IV East

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