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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Prime Time Seafood, Inc - Close Out Letter 6/27/11

  

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

 

June 27, 2011

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Rex N. Ito, President
Prime Time Seafood, Inc.
1515 E. 20th Street
Los Angeles, CA, 90011

Dear Mr. Ito:

The Food and Drug Administration has an evaluation of your written responses, results of our inspection conducted May 9th, 2011, and corrective actions to our Warning Letter WL # 06-11, dated October 15th, 2010. 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.

Sincerely,

/s/


David Whitman, Compliance officer
FDA- Los Angeles District Office
19701 Fairchild
Irvine, CA 92612