FDA Letter API

Bodyhealth.com, LLC

Letter data

Company
Bodyhealth.com, LLC
Recipient
Mr. David I. Minkoff | Owner | Bodyhealth.com, LLC | 745 Main St. | Dunedin | , | FL | 34698-5018 | United States | drminkoff@bodyhealth.com
Issue date
2021-12-17
Posted date
Not available
FDA office
Division of Human and Animal Food Operations East IV
Subject
Not available
Product
Dietary Supplements
CMS ID
610728
Reference number
21-HAFE4-WL-01
FEI
Not available
Inspection dates
Not available

Normalized citations

21 CFR: None found

21 U.S.C.: None found

Related FDA links

No related FDA letter link is present in the source index.

Full source text

CLOSEOUT LETTER Bodyhealth.com, LLC MARCS-CMS 610728 — December 17, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: 21-HAFE4-WL-01 Product: Dietary Supplements Recipient: Recipient Name Mr. David I. Minkoff Recipient Title Owner Bodyhealth.com, LLC 745 Main St. Dunedin , FL 34698-5018 United States drminkoff@bodyhealth.com Issuing Office: Division of Human and Animal Food Operations East IV United States Dear Mr. Minkoff: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to 21-HAFE4-WL-01, dated December 09, 2020. 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 Lopina Director of Compliance Branch OHAFO, Division IV East Content current as of: 12/17/2021 Regulated Product(s) Dietary Supplements