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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Catalina Offshore Products, Inc - Close out letter 3/14/11


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
FAX: 949-608-4415 


March 14, 2011

Mr. David J. Rudie
Catalina Offshore Products, Inc.
5202 Lovelock Street
San Diego, CA 92110

Dear Mr. Rudie:

The Food and Drug Administration has completed an evaluation of your written responses,
results of our inspection conducted December 13-15, 2010, and corrective actions to our
Warning Letter WL # 26-10, dated 06/14/10. 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 film 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
District Director
Los Angeles District