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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Galveston Shrimp & Fish Company, Inc. 03-Sep-08

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128


September 3, 2008

2008-DAL-WL-21

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Nello Cassarino, President
Galveston Shrimp & Fish Company, Inc.
P.O. Box 863
Galveston, Texas 77553

Dear Mr. Cassarino:

We inspected your seafood processing facility, Galveston Shrimp & Fish Company, Inc. located at 8011 Harborside Drive, Galveston, Texas on June 6, 10-12, 2008. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation Title 21, Code of Federal Regulations, Part 123 and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Parts 123 & 110). In accordance with 21 CFR § 123.6(g), failure of a processor of fish and fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your wahoo, amberjack, grouper, and snapper are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1. You must have a HACCP plan that, at a minimum, lists the critical limits (CL) that must be met, to comply with 21 CFR §123.6(c)(3). A "Critical Limit" is defined in 21 CFR § 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plans for "Wahoo", "Fish (Amberjack, Black Drum, Sheephead, Tuna, Mahi Mahi)", "Grouper" and "Snapper" list critical limits at the receiving critical control points (CCP) that are not adequate to control the food safety hazards associated with the particular species of fish, specifically histamine formation in Wahoo, Amberjack, Tuna, and Mahi mahi; and ciguatera (CFP) toxin in Snapper.

Specifically:

a. Your firm's HACCP plan for "Wahoo" lists critical limits at the "receiving" critical control point listed as "Be FULLY COOKED; CONTROL TIME AND TEMPERATURE" with the monitoring procedures of "AT RECEIVING MONITOR TEMPERATURE; PURCHASE ORDERS INDICATE TEMPERATURE" that are inadequate to control the food safety hazard of histamine. These provide no temperature or time critical limit values associated with receipt of fish as either a secondary or a primary processor. Purchase orders do not provide the information necessary to ensure that the hazard of histamine has been controlled during transit to your facility.

As a secondary processor, FDA recommends that your firm control the hazard of histamine by monitoring internal temperatures, adequacy of ice or cooling media, or assuring that transport temperatures were adequately maintained. For example:

1. When receiving fish in transit for short time periods (i.e., less than 4 hours) FDA recommends that internal temperature of a representative number of fish in a lot be monitored to ensure that the entire lot is received at or below 40°F.
2. When receiving fish in transit for long time periods, FDA recommends that temperatures be continuously monitored throughout the entire duration of the transit period. This is to ensure that no temperature fluctuations occurred during the transit period, exposing the fish to temperatures above 40°F for extended time periods. You may accomplish this by requiring time/temperature data records or some similar method of monitoring.
3. When receiving fish on ice or cooling media, FDA recommends monitoring for the presence of adequate ice or cooling media at receipt.

As a primary processor (receiving fish directly from the harvest vessels) FDA recommends that your firm control the hazard of histamine by:

o Taking internal temperatures on a representative number of fish (a minimum of 12 or the entire lot if less fish are in the lot). The recommended safe internal temperatures vary with the length of time from capture. The Fish and Fisheries Products Hazards and Controls Guidance, 3rd Edition, can help you determine an appropriate critical limit;
AND
o Obtaining harvest vessel records that include the following information: method of capture, date and time of landing; estimated time of death of fish; air/water temperatures; method of cooling on board the vessel; date/time cooling began; cooling rate including any additional factors demonstrating adequate cooling, for example the internal temperature after 6 hours; storage controls; and date and time of off-loading;
OR
o conducting histamine testing on a representative number of fish in the lot:
AND
o Conducting sensory evaluation on a representative number of fish in the lot.

b. Your firm's HACCP plan for "Fish (Amberjack, Black Drum, Sheephead, Tuna, and Mahi-Mahi)" lists critical limits at the "receiving" critical control point that are inadequate to control the food safety hazard of histamine. As discussed above, the monitoring procedures necessary when your firm acts as a secondary processor should not be same as when your firm acts as a primary processor.

> As a secondary processor, your monitoring procedure listed as "PACKED VISUAL ON ICE" does not match your critical limits listed as "CONTROL TIME AND TEMPERATURE". If your firm intends to monitor the presence of ice, your critical limits should list "adequate ice surrounding the product."

> As a primary processor (receiving fish directly from the harvest vessels) FDA recommends that your firm control the hazard of histamine by:

o Taking internal temperatures on a representative number of fish (a minimum of 12 or the entire lot if less fish are in the lot). The recommended safe internal temperatures vary with the length of time from capture. The Fish and Fisheries Products Hazards and Controls Guidance, 3rd Edition, can help you determine an appropriate critical limit.
AND
o Obtaining harvest vessel records that include the following information: method of capture, date and time of landing; estimated time of death of fish; air/water temperatures; method of cooling on board the vessel; date/time cooling began; cooling rate including any additional factors demonstrating adequate cooling, for example the internal temperature after 6 hours; storage controls; and date and time of off-loading;
OR
Conducting histamine testing on a representative number of fish in the lot;
AND
o Conducting sensory evaluation on a representative number of fish in the lot.

c. Your firm's HACCP plan for "Snapper" lists pen and ink changes for the receiving critical control point (CCP) to identify the significant food safety hazard of ciguatera toxin
(CFP). However, your pen and ink changes listed as "Adequacy of Ice surrounding product" for the critical limits and monitoring procedures to control CFP are inadequate because they do not address the need to monitor the harvest areas/locations to ensure that fish are not harvested from areas where ciguatoxic fish have been previously harvested.

2. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical or physical property that may cause a food to be unsafe for human consumption." However your firm's HACCP plan for "Grouper" does not list the food safety hazard of ciguatera toxin.

In addition, your firm's HACCP plan for ""Fish," which includes Amberjack does not list the food safety hazard of ciguatera toxin associated with the Amberjack.

Furthermore, your HACCP plan for "Fish" includes Black Drum and Sheephead as two of the various species that you receive in association with this plan. However, these two species do not pose a hazard for histamine, as identified in this plan. We suggest a separate plan for these species to address the significant hazard of environmental chemicals.

3. In addition to the aforesaid deviations, your product labeled as "American Red Snapper" (50 lbs) is misbranded within the meaning of section 403(e)(1) [21 U.S.C. §342(e)(1)] of the Act for failing to bear the name and place of business of the manufacturer, packer, or distributor as specified by 21 CFR 101.5(a).

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

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as revised HACCP plans, receiving records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

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 Regulation and the Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (214) 253-5220.

Sincerely,

/S/

Renaldo R. Rodriguez, Jr.
Dallas District Director

RRR:cap