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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Coastal Implant Technologies, Inc. - Close Out Letter 4/27/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

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.

Sincerely,

/s/

Alonza E. Cruse
District Director
Los Angeles District