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CLOSEOUT LETTER

Sea World, Inc.


Sea World, Inc.

 

  

Black HHS-Blue FDA Logo

 

Office of Regulatory Affairs
Division of Human and Animal Food, East IV
Compliance Branch
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel: (787) 729-8500 

 
 

September 12, 2017

17-HAFE4-WLCOL-07

VIA UNITED PARCEL SERVICE
NEXT DAY- SIGNATURE REQUIRED

Mr. Eric Charak, President
Sea World, Inc.
3816 Crown Bay, Charlotte Amalie
St. Thomas, Virgin Islands 00802-6159

Re: 12-SJN-WL-06 / CMS No. 296858

Dear Mr. Charak:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 12-SJN-WL-06 dated May 01, 2012. 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/

Edwin Ramos
Director of Compliance Branch
Division of Human and Animal Food, East IV