Electronic Development Labs, Inc - Close Out Letter 6/18/15
- Electronic Development Labs, Inc
Department of Health and Human Services
|Food and Drug Administration|
Baltimore District Office
6000 Metro Drive
Baltimore, MD 21201-2199
Telephone: (410) 779-5455
FAX: (410) 779-5705
June 18, 2015
Mr. Donald M. Polsky, CEO
Electronic Development Labs, Inc.
244 Oakland Drive
Danville, VA 24540-7342
Dear Mr. Polsky.
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (#423609) dated October 1, 2014 and a follow-inspection conducted March 26, 2015. Based on our evaluation, it appears that you have 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.
CDR Rochelle B. Young, RPh, MSA
Compliance Officer, Baltimore District Office