Inspections, Compliance, Enforcement, and Criminal Investigations
Automated Ophthalmics, Inc. - Close Out Letter 2/18/14
Department of Health and Human Services
|Food and Drug Administration|
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
Fax: (410) 779-5705
February 18, 2014
WARNING LETTER CLOSE-OUT LETTER
Mr. Brian Congleton, President
Automated Ophthalmics, Inc.
6671 Santa Barbara Road, Suite F
Elkridge, Maryland 21075
Dear Mr. Congleton:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated June 12, 2013 (CMS # 395044). 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.
Ernest F. Bizjak