FDA Letter API

Legendary Nutrition, LLC

Letter data

Company
Legendary Nutrition, LLC
Recipient
Dave Rodely | Legendary Nutrition, LLC | 361 Southwest Drive #136 | Jonesboro | , | AR | 72401 | United States
Issue date
2019-11-26
Posted date
Not available
FDA office
Division of Enforcement
Subject
Not available
Product
Dietary Supplements
CMS ID
486995
Reference number
Not available
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 Legendary Nutrition, LLC MARCS-CMS 486995 — November 26, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Dietary Supplements Recipient: Recipient Name Dave Rodely Legendary Nutrition, LLC 361 Southwest Drive #136 Jonesboro , AR 72401 United States Issuing Office: Division of Enforcement United States Dear Mr. Dave Rodely: The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #486995, issued March 7, 2016. Based on our evaluation, it appears you have addressed the violations contained in the 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/ Carrie Lawlor Branch Chief Dietary Supplement and Labeling Assessment Branch Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 05/21/2020 Regulated Product(s) Dietary Supplements