- Delivery Method:
- Express Delivery
Jon E. Fridriksson
- Fisk Seafood ehf
- Issuing Office:
- Center for Food Safety and Applied Nutrition
JAN 11, 2017
VIA EXPRESS DELIVERY
Jon E. Fridriksson, General Manager
Fisk Seafood ehf
Reference # 512748
Dear Mr. Fridriksson:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Fisk Seafood ehflocated at Nesvegi 4, 350 Grundarfjordur, Iceland on September 12 and 13, 2016. That inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your response received via email dated October 4, 2016, which included documentation describing corrections to the observations of concern noted on the form FDA-483, a revised HACCP plan dated September 30, 2016, along with some supporting documents and photographs of corrective actions. However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
In accordance with 21 CFR 123.6(g), failure of a seafood processing facility 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 individually quick frozen, cooked and peeled shrimp products 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 Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on 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/guidanceregulation/guidancedocumentsregulatoryinformation/seafood/ucm2018426.htm
We note the following significant deviations:
1) 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 21CFR 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 individually quick frozen, cooked and peeled shrimp does not list the food safety hazard(s) of Clostridium botulinum toxin formation and sulfite sensitivity.
During the inspection, our investigator noted that your packaging does not meet the minimum recommended oxygen transmission rate of 10,000 cc/m2/24 hours at 24°C to eliminate the hazard of C. botulinum toxin formation. Consequently, your firm needs to identify and control the hazard of Clostridium botulinum toxin formation. Once identified, your firm should control the hazard by ensuring that all packages of your frozen shrimp products are labeled with handling instructions such as “Keep Frozen, Thaw Under Refrigeration Immediately Before Use”. Further, your HACCP plan fails to identify the hazard of sulfite sensitivity. We acknowledge that you submitted a document that appears to reference sulfites; however, this document was not in English and it is not clear how this document relates to you HACCP plan. Your firm needs to ensure that for shrimp that have been treated with sulfites, the presence of the sulfites are listed on the labels.
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 firm’s HACCP plan for individually quick frozen, cooked and peeled shrimp lists a critical limit of “(b(4) in the center of shrimp. If temperature in the center is less than 74°C then take a corrective action”at “Steam Cooker” critical control point that is not adequate to control the pathogen hazard (listed in your plan as “(b)(4)”). FDA considers your critical limits at this step to be the most conservative internal temperature of 74°C with no corresponding time. FDA recommends that firms achieve a 5 log reduction for Listeria monocytogenes during the cook cycle for Ready-to-Eat products such as your cooked shrimp. To achieve a 5 log reduction for Listeria monocytogenes, using your current method of end-point internal product temperature (EPIPT) your firm would need to ensure that all of the shrimp in the batch achieved and maintained 74°C for 36 seconds under worse case conditions (i.e., largest coldest shrimp in the batch). An alternative to EPIPT is to list critical limits for the cooking apparatus and to monitor cooking time and cooking temperature to ensure product maintains an internal temperature of 74°C for 36 seconds, or other time and temperature combinations that achieve equivalent and adequate inactivation of Listeria monocytogenes. Your firm should base your cook on a study conducted under worse case conditions to ensure consistent replication of the schedule cook process so all shrimp achieve an adequate cook during production. When using cooking time and temperatures of the apparatus your firm should consider additional critical limits such as belt speed, size of the shrimp, and other critical factors that affect the cooking process. Additionally belt speed for the cooking apparatus should be continuously monitored and recorded during the cooking process.
3) You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for protection of food and packaging material from adulteration, proper labeling and storage of toxic compounds and exclusion of pests in the processing areas required for the processing of individually quick frozen, cooked and peeled shrimp for the week of August 29, 2016. We acknowledge your response and request the appropriate documentation demonstrating that you have made the necessary corrections.
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. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, such as documentation reflecting the changes you made, such as a copy of your revised HACCP plan, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, 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 seafood HACCP regulation. 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. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/importalert_25.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 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.
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 the Food and Drug Administration, Attention: Marco Esteves, Compliance Officer,Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Marco Esteves via email at email@example.com
Please reference #CMS 512748 on any submissions and within the subject line of any emails to us.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition
Mr. Arni Halldorsson, Plant Manager
Fisk Seafood ehf