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CLOSEOUT LETTER

Conrad Shada


Conrad Shada

 

  

Black HHS-Blue FDA Logo

 

 

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

February 3, 2017
 

Via United Parcel Service (UPS)
 

Conrad Shada
405 Old Dubuque Rd.
Anamosa, IA 52205
 

Ref.: CMS # 484337
 

Dear Mr. Shada:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [Ref.: CMS # 484337] dated December 4, 2015. Based on our evaluation, 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.

Sincerely,
/S/

Cheryl A. Bigham
District Director
Kansas City District Office