Inspections, Compliance, Enforcement, and Criminal Investigations
Gabrimar Export Fish, S.A. 12/8/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
December 8, 2011
VIA EXPRESS MAIL
Reference No. 237034
Mr. Omar Rodriguez, President
Gabrimar Export Fish, S.A.
Urbanizacion Los Angeles,
Chalet 7A, Tuba Muerto,
Panama City, Panama
Dear Mr. Rodriguez:
On July 27 – 28, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood manufacturing facility, Gabrimar Export Fish, S.A., located at Urbanizacion Los Angeles, Chalet 7A, Panama City, Panama. We found that you have serious deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. We have not received any response from your firm.
Failure of a processor to have and implement a HACCP plan that complies with 21 CFR 123.6(g), or otherwise in accordance with the requirements of 21 CFR part 123, renders the 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 firm’s Fresh, Whole Mahi Mahi HG appears to be adulterated, in that the products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulation through links in FDA’s home page at www.fda.gov.
Your significant violations are as follows:
1. 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.” Your firm’s HACCP plan for various fresh whole fish, including scombrotoxin-forming species appears to use histamine testing as your strategy for controlling histamine at receipt, when the (b)(4). However, your plan lists histamine testing only (b)(4)as a verification step. Your HACCP plan should list a critical limit for histamine testing and monitor each shipment if that is your intended method of control. FDA currently recommends a critical limit of 50 ppm and testing at least 18 fish of the same species per lot. Requiring harvest vessel records for each shipment is an alternative to histamine testing. The Fish and Fisheries Products Hazards and Controls Guidance can provide you with additional information on what information acceptable harvest vessel records contain http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm. The HACCP plan only listed two critical limits at the receiving CCP: (b)(4). These controls are adequate only in conjunction with either reviewing harvest vessel records or conducting histamine testing as the third component of your critical limit to control histamine. Your firm also processes grouper and snapper, and has submitted a separate HACCP plan for controlling ciguatera fish poisoning (CFP) containing fish. At the receiving CCP, the critical limit of “Free of CFP and other substances” is inappropriate in that it does not ensure that (b)(4). Testing is not normally an option for CFP and is not a reliable indicator.
2. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for scombrotoxin forming fish at the storage critical control point (CCP) to control histamine production is not appropriate. Specifically at the storage CCP, the corrective action of (b)(4). An evaluation based on time and temperature cannot be determined without continuous monitoring.
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. Your response should include documentation, such as: a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. This alert can be found on FDA’s web site at: http://www.fda.gov/ora/fiars/ora_import_ia16120.html
Please send your reply to the Food and Drug Administration, Attention: Carol D’lima, Consumer Safety Officer, CFSAN Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Carol.Dlima@fda.hhs.gov. Please reference FEI #3004353769 on any submissions and within the subject line of any emails to us. You may also contact Carol D’lima at (240) 402-2033 or email if you have any questions about this letter.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety and Applied Nutrition