U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. AG Industries LLC - Close Out Letter 5/19/17
  1. Compliance Actions and Activities

CLOSEOUT LETTER

AG Industries LLC May 19, 2017

AG Industries LLC - Close Out Letter 5/19/17


AG Industries LLC

 

  

Black HHS-Blue FDA Logo

 

 

 
Kansas City District Office
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100

May 19, 2017

DELIVERY VIA UPS

WARNING LETTER CLOSE-OUT LETTER

Samantha L. Bonano, President
AG Industries LLC
3637 Scarlet Oak Blvd.
Saint Louis, MO 63122-6605

Dear Ms. Bonano:

The Food and Drug Administration has completed an evaluation of AG Industries LLC corrective actions in response to our Warning Letter (CMS case #: 469782) on June 12, 2015. 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/

Miguel A. Hernandez
Director, Compliance Branch
Kansas City District