CLOSEOUT LETTER
Automated Ophthalmics, Inc.
- Recipient:
- Automated Ophthalmics, Inc.
United States
- Issuing Office:
United States
| |
| Food and Drug Administration Baltimore District Office Central Region 6000 Metro Drive, Suite 101 Baltimore, MD 21215 Telephone: (410) 779-5455 Fax: (410) 779-5705 |
Department of Health and Human ServicesFEI: 3005906810
February 18, 2014
VIA UPS
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.
Sincerely,
/S/
Ernest F. Bizjak
Compliance Officer
Baltimore District