CLOSEOUT LETTER

Flavour Makers Pty Ltd August 03, 2017

Recipient:: Flavour Makers Pty Ltd; United States

Issuing Office:: United States


Department of Health and Human Services	Public Health Service Food and Drug Administration
	College Park, MD 20740

August 3, 2017

Mr. Alex Severino
Quality Assurance Manager
Flavour Makers Pty., Ltd.
Dry Blending Facility
91-97 Woodlands Drive
Braeside, Victoria, 3195, Australia

Dear Mr. Severino:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #396095, issued September 12, 2013. 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/

Mildred P. Benjamin
Branch Chief
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

Department of Health and Human Services