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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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The Egg Roll Castle Company 16-Apr-02

Department of Health and Human ServicesDepartment of Health and Human Services            Public Health Service


Food and Drug Administration
19900 MacArthur Blvd., Ste 300
Irvine, California 92612-2445
Telephone (949) 798-7600

WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
April 16, 2002

WL-33-02-Rev

Symmonette B. LaGrua, President/Owner
The Egg Roll Castle Company
8535 Arjons Drive, Suite W
San Diego, California 92126

Dear Ms. LaGrua:

We inspected your seafood processing facility, located at 8535 Arjons Drive, Suite W, San Diego, California 92126 on November 8 - 13, 2001 and found that you have serious deviations from the Seafood HACCP regulations (21 CFR Part 123). These deviations, some of which were previously brought to your attention, cause your fishery products to be in violation of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. You can find this Act and the seafood HACCP regulations through links in FDA?s home page at www.fda.gov.

The deviations were as follows:

  1. You must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(b). However, your firm does not have a HACCP plan for your frozen Shrimp Lumpia to control the food safety hazard of undeclared allergenic/additives ingredients. Please be aware that this deviation was previously brought to your attention in our letter of June 21, 2000.

You should take prompt action to correct this deviation. Failure to promptly do so may result in regulatory action without further notice, such as seizure and/or injunction. .

Please notify this office in writing, within fifteen (15) working days of receipt of this letter, of specific steps you have taken to correct the noted violation and to prevent it?s recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. You may wish to include in your response documentation such as HACCP plans, monitoring forms and recent monitoring data or other useful information that would assist us in evaluating your corrections.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations and the Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

If you have any questions relating to this letter you should contact Robert B. McNab, Compliance Officer, at (949) 798-7709. Your written reply should be addressed to:

Thomas L. Sawyer, Director, Compliance Branch
U. S. Food and Drug Administration
19900 MacArthur Boulevard, Suite 300
Irvine, California 92612-2445

Sincerely,

/s/

Alonza E. Cruse, Director

Los Angeles District