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  5. Improva Herbal Products - 07/12/2017
  1. Warning Letters

CLOSEOUT LETTER

Improva Herbal Products


Recipient:
Improva Herbal Products

United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740 

July 12, 2017
 

Mr. Pradip Patil, Quality Assurance Head and Partner
Mr. Gulab Walunj, Production Head and Partner
Improva Herbal Products
Sai Kiran Complex
Rh C3 Sambhagi Nagar, Chinchwad
Puna, India
 

Dear Mr. Patil and Mr. Walunj:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter issued December 15, 2015. 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/

Brandon Bridgman
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Brandon Bridgman