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IDT Australia Ltd. MARCS-CMS 547605 —

Reference #:
FEI 3000219354

Recipient Name
Dr. David Sparling
Recipient Title
IDT Australia Ltd.

45 Wadhurst Drive
Boronia VIC 3155

Issuing Office:
Center for Drug Evaluation and Research

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

Dear Dr. Sparling:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-18-55 dated May 23, 2018. Based on our evaluation, it appears that you have addressed the violations and deviations 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 FDA 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 and deviations be observed during a subsequent inspection or through other means.

Bryce A. Hammer
Compliance Officer
Division of Drug Quality II

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