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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Fresh Island Seafood Hub 25-Jun-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510-337-6700

CERTIFIED MAIL
RECEIPT REQUESTED
June 25, 2001

Our Reference: 2954511
WARNING LETTER

Edward H. Poppe, Jr., President
Fresh Island Seafood Hub
P. O. BOX 20249
Guam Main Facility, Guam 96921

Dear Mr. Poppe:

On April 13 and 17, 2001, we inspected your seafood facility located at Route 8, Maite, Guam to determine your compliance with FDA?s Seafood HACCP regulations, 21 Code of Federal Regulations (21 CFR 123) and the Good Manufacturing Practice (GMP) requirements for foods (21 CFR 110).

We found that your firm has serious HACCP deviations. These deviations cause your Mahi-mahi and Wahoo to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), in that the fish have been prepared, packed, or held under insanitary conditions, whereby they may be rendered injurious to health. We listed the deficiencies on a Form FDA 483 (Inspectional Observations) and discussed them with you at the conclusion of the inspection. The deviations are as follows:

1. You must have a HACCP plan that lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(c)(1). However, your firm?s HACCP plan for pelagic fish does not list the food safety hazard of histamine formation as a result of time/temperature abuse in Mahi-mahi and Wahoo.

2. You must have a HACCP plan that lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). However, your firm?s HACCP plan for pelagic fish lists a critical limit at the receiving critical control point (CCP) that is not adequate to control histamine formation in Mahi-mahi and Wahoo.

3. You must implement the record keeping system listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the receiving (Fishing vessel) and processing facility (refrigerators) CCPS.

4. Since you chose to include corrective actions in your HACCP plan, your described corrective action must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for pelagic fish at the processing facility (refrigerators) CCP to control histamine formation are not appropriate. Specifically, making repairs to the equipment is not adequate. This does not prevent the introduction into commerce of adulterated product.

5. You must adequately monitor and document sanitation conditions and practices, to comply with 21 CFR 123.11(b) and (c). However, your firm did not monitor and maintain records related to the following areas of sanitation to ensure control:

a) Safety of water;

b) Condition and cleanliness of food contact surfaces;

c) Prevention of cross-contamination;

d) Maintenance of hand washing, hand sanitizing, and toilet facilities;

e) Protection of food and food contact surfaces from adulterants;

f) Proper labeling and storage of toxic compounds;

g) Control of employee health conditions; and

h) Exclusion of pests from the processing area.

We may take further regulatory action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.

Please respond in writing within fifteen(15) working days of receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You may wish to include in your response documentation such as time/temperature monitoring records, sanitation records, revised HACCP plans, etc. If you cannot complete all the corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deficiencies.

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

Please send your reply to the Food and Drug Administration, Attention: Erlinda N. Figueroa, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, California 94502-7070. If you have questions regarding any issue in this letter, please contact Ms.Figueroa at (510) 337-6795.

Sincerely,

/s/
Dennis K. Linsley
Director
San Francisco District