Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch ParkwayCollege Park, MD 20742
October 2, 2014
VIA EXPRESS DELIVERY
Director Geral Fábrica
Gialmar – Produtos Alimentares SA
Parque Industrial Lote 47/48, Gala
Figueira Da Foz, Portugal 3090380
Reference No. # 439048
Dear Mr. Doque:
In response to deviations from the United States Food and Drug Administration’s seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123 found during an inspection that we conducted at your seafood processing facility, Gialmar – Produtos Alimentares SAlocatedat Parque Industrial Lote 47/48, Figueira Da Foz, Portugal,on February 11-12, 2014, your firm provided documentation via emails on March 7, 2014 and July 17 and 18, 2014, to address those deviations.
The documentation you provided included your revised HACCP plan (i.e., English version) via email on July 18, 2014. Our evaluation of your revised HACCP plan revealed continuing concerns with your firm’s operations as further described in this letter.
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 fresh and frozen sardines, mackerel, and horse mackerel are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Your significant deviations 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." However, your firm’s revised HACCP plan (i.e., English version) provided with your July 18, 2014 email for your fish and fishery products lists critical limits that are not adequate to control scombrotoxin (histamine) formation in your sardines, mackerel, and horse mackerel.
At the “(b)(4)” critical control point your HACCP plan only lists critical limits for (b)(4). However, these alone are not adequate to control the hazard of scombrotoxin (histamine) formation because they do not include parameters that ensure the fish were properly handled onboard the harvest vessels. As a primary processor receiving the fish directly from the harvest vessels, FDA recommends critical limits at receiving also include conducting histamine analysis on a representative sample of scombrotoxin-forming fish to show less than 50 ppm histamine in all fish in the sample; or obtaining harvest vessel records to demonstrate the handling practices aboard the vessels. Additionally, FDA recommends for sensory examination that less than 2.5% in a sample of 118 fish show signs of decomposition. For example, no more than 2 fish in a sample of 118 fish may show signs of decomposition.
In addition, while your HACCP plan lists “(b)(4)”, there is no indication whether this temperature reflects internal fish temperature or surface temperature. Moreover, FDA recommends that primary processors conduct internal temperature checks of the fish at the time of off-loading from the harvest vessels to ensure that the fish were held at proper temperatures while onboard the vessels.
2. 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 revised HACCP plan (i.e., English version) provided with your July 18, 2014 email for your fish and fishery products lists a monitoring procedure/frequency at the “(b)(4)” critical control point that is not adequate to control scombrotoxin (histamine) formation. Your monitoring procedure for sensory examinations states “(b)(4)”. For sensory examinations, as mentioned above, FDA recommends examining at least 118 fish, collected representatively throughout each lot, or the entire lot for lots smaller than 118 fish.
3. Predetermined corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). However, your corrective action plan for your fish and fishery products list inadequate corrective actions to control scombrotoxin (histamine) formation.
a. Your corrective action plan at the “(b)(4)” critical control point is not appropriate. FDA recommends that when the internal product temperature exceeds the critical limit, you chill and hold the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the lot, or the entire lot for lots smaller than 60 fish. If any fish is found with histamine greater than or equal to 50 ppm, then reject the entire lot. In addition, discontinue use of the supplier or carrier until there is evidence that the identified transportation-handling practices have been improved.
b. Your corrective action plan at the “(b)(4)” critical control point is not appropriate. Your corrective action lists “(b)(4).” For storage temperature critical limit deviation, FDA recommends you chill and hold the product until it can be evaluated based on its total time and temperature exposure (i.e., since your firm references the use of a continuous monitoring and recording device to monitor the storage temperatures at this critical control point), including exposures during prior processing operations. Alternatively, you may chill and hold the affected product until histamine analysis is performed on a minimum of 60 fish collected from throughout each affected lot, and if histamine greater than or equal to 50 ppm is found in any fish, destroy the lot or divert it to a non-food use.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or plans, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations. Submission of the information in English will assist in our review. If you cannot complete all corrections within 15 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 imported 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. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html
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 and all applicable regulations, including the Seafood HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Additionally, Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to Food and Drug Administration, Attention: Sheena Crutchfield, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Crutchfield via email at email@example.com.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition