- Compumedics Germany Gmbh
10903 New Hampshire Avenue
Silver Spring, MD 20993
February 2, 2017
General Manager and CEO
RE: FDA Reference Number COR16000605
Dear Mr. Witte:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated August 1, 2012. 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.
Office of In Vitro Diagnostics and
Center for Devices and