DNA Genotek Inc. - Close Out Letter 8/1/17
- DNA Genotek Inc.
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Ave.|
Silver Spring, MD 20993-0002
AUG 1, 2017
Senior Vice President and General Manager
DNA Genotek Inc.
500 Palladium Drive, Ottawa
Ontario K2V 1C2 Canada
Dear Brian Smith:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated December 20, 2013. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this Warning Letter.
This letter does not relieve 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. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Donald J. St. Pierre
Acting Deputy Director for
Patient Safety and Product Quality
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health