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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Alfa International Seafood, Inc. & Gamma Seafood Corporation 24-Jan-08

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

Public Health Service
Food and Drug Administration

 

555 Winderley Place, Ste. 200
Maitland, Florida 32751
Telephone: (407)475-4700
FAX: (407) 475-4769

WARNING LETTER

FLA-08-07

January 24, 2008

Gabriel A. Alvarez, President.
Alfa International Seafood, Inc. &
Gamma Seafood Corporation
7401 NW 74th Avenue
Medley, Florida 33166-2420

Dear Mr. Alvarez:

We inspected your seafood processing and importer establishments, Alfa International Seafood, Inc. (AIS) and Gamma Seafood Corporation (GSC), located at the address listed above on August 28-31 and September 6, 11 & 12, 2007. 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 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 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 seafood products 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:

• You must conduct a hazard analysis 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 critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123 .3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.", However, your firm's HACCP plan at Alfa International Seafood (AIS) for "Fresh Fish Loins (Vacuum Packed/10K OTR Bag Packed) Escolar/Blue Marlin/Swordfish/Tuna" and your firm's HACCP plan at Gamma Seafood Company (GSC) for "Fresh Fish Fillet (Vacuum Packed/10K OTR Bag Packed) Corvina/Grouper/Kingklip/Mahi/Seabass/Snapper/Tilapia/Triple Tail" do not list the critical control points (CCPs) associated with the use of TTIs on your reduced oxygen packaged fresh seafood to control the food safety hazard of C. botulinum growth and toxin formation. FDA recommends CCPs covering the receipt of TTIs, activation of TTIs, and the application of TTIs. The food safety hazard C. botulinum only applies to those products packed reduced oxygen packaging, not those packaged in 10K OTR bags. (AIS FDA-483, Item #2/GCS FDA-483; Item #2).

• You must have a HACCP plan that, at a minimum, lists the critical limits 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 firms' HACCP plans for:

o "Fresh Fish Amberjack/Mackerel/Mahi/Blue Marlin/Tuna/Wahoo" at AIS and GSC list a critical limit, "Product exposed to ambient temperatures above [redacted]F) for more than [redacted] hours cumulatively. . ." at the "Product Storage" critical control point that is not adequate to control histamine (scombrotoxin) formation. This limit does not ensure control of the histamine formation hazard. (AIS FDA 483, Item #3b/GCS FDA-483, Item #lb).

o "Fresh Fish Loins (Vacuum Packed/10K OTR Bag Packed) Escolar/Blue Marlin/Swordfish/Tuna" at AIS and "Fresh Fish Fillet (Vacuum Packed/10K OTR Bag Packed) Corvina/Grouper/Kingklip/Mahi/Seabass/Snapper/Tilapia/Triple Tail" at GSC list a critical limit, "Product exposed to ambient temperatures above [redacted]C [redacted]F) for more than [redacted] hours cumulatively. . .", at the "Product Storage" critical control point that is not adequate to control histamine formation hazard and C. botulinum growth and toxin formation. This limit does not ensure control of the histamine formation hazard and the C. botulinum growth and toxin formation hazard. The food safety hazard C. botulinum only applies to those products packed in reduced oxygen packaging, not those packaged in 10K OTR bags. (AIS FDA-483, Item #3c/GCS FDA-483, Item #1c).

• You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control histamine (scombrotoxin) formation and C. botulinum toxin formation when your process for vacuum packed blue marlin deviated from your critical limit at the "Grading and Control" critical control point. Specifically, on August 27-30, 2007 you deviated from your critical limit at the "Grading and Control" critical control point on the HACCP plan for "Fresh Fish Loins (Vacuum Packed/10K OTR Bag Packed) Escolar/Blue Marlin/Swordfish/Tuna" in that you accepted a shipment of vacuum packed raw refrigerated blue marlin loin with Fresh. Check brand TTIs, that had changed color, and distributed the product without following the corrective actions listed in your plan. (AIS FDA-483, Item #4).

• You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm's HACCP plans for:

o "Fresh Fish Amberjack/Mackerel/Mahi/Blue Marlin/Tuna/Wahoo" at AIS and GSC; "Fresh Fish Loins (Vacuum Packed/10K OTR Bag Packed) Escolar/Blue Marlin/Swordfish/Tuna" at AIS; and "Fresh Fish Fillet (Vacuum Packed/10K OTR Bag Packed) Corvina/Grouper/Kingklip/Mahi/Seabass/Snapper/Tilapia/Triple Tail" at GSC lists a monitoring. procedure and frequency at the "Product Storage" critical control point that is not adequate to control histamine and C. botulinum toxin formation. FDA recommends continuous monitoring of the cooler with a visual check once per day. It was noted during the inspection that your firm has an outside company to monitor your cooler with a 24/7 high temperature alarm however this continuous monitoring procedure is not listed in the HACCP plans. (AIS FDA-483, Item #5b/GCS FDA-483, Item #4b).

o "Fresh Fish Loins (Vacuum Packed/10K OTR Bag Packed) Escolar/Blue Marlin/Swordfish/Tuna"at AIS; and "Fresh Fish Fillet (Vacuum Packed/10K OTR Bag Packed) Corvina/Grouper/Kingklip/Mahi/Seabass/Snapper/Tilapia/Triple Tail"at GSC lists a monitoring frequency at the Grading and Control critical control point that is not adequate to control the food safety hazard of C. botulinum toxin formation in reduced oxygen permeable packaging. Rather than checking the internal temperature in [redacted] boxes of incoming product, you must ensure the safety of vacuum-packaged products throughout transit. FDA recommends using a digital data recorder, or other means of continuous monitoring, during transit to your firm, with a visual check upon receipt.

• Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for "Fresh Fish AmberJack/Mackerel/Mahi/Blue Marlin/Tuna/Wahoo" at AIS and GSC; "Fresh Fish Loins (Vacuum Packed/10K OTR Bag Packed) Escolar/Blue Marlin/Swordfish/Tuna" at AIS; and "Fresh Fish Fillet (Vacuum Packed/10K OTR Bag Packed) Corvina/Grouper/Kingklip/Mahi/Seabass/Snapper/Tilapia/Triple Tail" at GSC at the "Grading and Control" critical control point to control histamine and C. botulinum toxin formation is not appropriate. Specifically, the corrective action listed is inadequate in that it does not include corrections as a result of inadequate presence of ice such as rejecting the product, performing histamine testing or holding the product for evaluation and discontinue the use of supplier. (AIS FDA-483, Item #7/GCS FDA-483, Item #6).

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 in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4) and the seafood HACCP regulation.

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 HACCP and importer verification records, records that document the performance and results of your firm's affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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 violations at your facility. You are responsible for ensuring that your seafood establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123) and the Current 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 for your fish or fishery products, including those that you import into the United States.

Please send your reply to the Food and Drug Administration, Attention: Brant M. Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions regarding any issue in this letter, please contact Mr. Schroeder at (407) 475-74763.

Sincerely,

/S/

Emma R. Singleton
Director, Florida District