CLOSEOUT LETTER
Neomedix Corp
- Recipient:
- Neomedix Corp
United States
- Issuing Office:
United States
| |
| Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
MAY 21, 2014
Soheila Mirhashemi
President & CEO
NeoMedix Corporation
15042 Parkway Loop
Suite A
Tustin, California 92780-6528
Dear Ms. Mirhashemi:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS #420853 dated February 26, 2014). Based on our evaluation, it appears that you have addressed the violations 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 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 yours,
/S/
Anastacia M. Bilek, Ph.D.
Director
Division of Premarket
and Labeling Compliance
Office of Compliance
Center for Devices and
Radiological Health