Inspections, Compliance, Enforcement, and Criminal Investigations
Coastal Implant Technologies, Inc. - Close Out Letter 4/27/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
April 27, 2012
Mr. Steven S. Grand, CEO
Coastal Implant Technologies, Inc.
1407 N. Batavia St., STE 110
Orange, CA 92867
Dear Mr. Grand:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (WL #24-11 dated February 3, 2011). 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.
Alonza E. Cruse
Los Angeles District