Inspections, Compliance, Enforcement, and Criminal Investigations
Leong-Kuba Sea Products, Inc - Close Out Letter
| Public Health Service Food and Drug Administration |
Los Angeles District |
Department of Health and Human Services
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
September 27, 2011
Mr. Glen Y. Kuba, President
Leong-Kuba Sea Products, Inc.
6230 Marindustry Dr.
San Diego, CA 92121
Dear Mr. Kuba:
The Food and Drug Administration has completed an evaluation of your written responses, results of our inspection conducted August 23-25, 2011, and corrective actions to our Warning Letter WL # 26-11, dated February 16, 2011. 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/
Alonz E. Cruse
District Director
Los Angeles District
