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CLOSEOUT LETTER

Tata Harper Skincare Mar 02, 2017

Tata Harper Skincare - Close Out Letter 3/2/17


Tata Harper Skincare

 

  

Black HHS-Blue FDA Logo

 

 

 
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556 

UNITED PARCEL SERVICE
OVERNIGHT DELIVERY

March 2, 2017

Tata Harper, Owner
Tata’s Natural Alchemy, LLC
1135 Wooster Road
Whiting, VT 05778

Dear Ms. Harper:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 498011 dated August 1, 2016. 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/

Lori A. Holmquist
Acting District Director
New England District Office