FDA Letter API

GumRunner, LLC

Letter data

Company
GumRunner, LLC
Recipient
GumRunner, LLC | United States
Issue date
2018-03-27
Posted date
Not available
FDA office
United States
Subject
Not available
Product
Not available
CMS ID
Not available
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 GumRunner, LLC March 27, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: GumRunner, LLC United States Issuing Office: United States 5001 Campus Drive College Park, MD 20740 March 27, 2018 Laurence B. Molloy, Co-Owner Candy Treasure, LLC 66 Welsh Rd. Lebanon, NJ 08833 Via email: (b)(6) @candytreasure.com Dear Mr. Molloy: The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #398518, issued August 22, 2013. 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/ Latasha A. Robinson 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: 04/18/2018