Inspections, Compliance, Enforcement, and Criminal Investigations
Aersher Diagnostics, LLC - Close Out Letter 3/19/12
| Public Health Service Food and Drug Administration |
Baltimore District Office |
Department of Health and Human ServicesFEI: 1000219815
March 19, 2012
Certified Mail
Return Receipt Requested
Robert Schreiber, MD, CEO
Aersher Diagnostics, LLC
125 Dixon Drive
Chestertown, MD 21620
Dear Dr. Schreiber:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS 178032 dated June 28, 2011. Based on our evaluation, it appears that you have adequately addressed the violation(s) 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/
Cherlita Honeycutt
Compliance Officer
Baltimore District
