- Sevrin Tranvag AS
- Issuing Office:
- Center for Food Safety and Applied Nutrition
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
MAR 10, 2015
VIA EXPRESS DELIVERY
Mr. Sevrin Tranvag, Co-owner/Managing Director
Sevrin Tranvag AS
Fiskarstrand, Norway 6035
Reference # 449620
Dear Mr. Tranvag:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, Sevrin Tranvag AS, located at Tranvagen 6, Fiskarstrand, Norway, on September 2 and 3, 2014. During that inspection, we found that you had violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the observations made at your firm.
We acknowledge your written response dated September 19, 2014, which included pictures of your corrective actions and a risk analysis. However, your finn did not provide a HACCP plan for your fish and fishery products.
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 mackerel 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: www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm.
We note the following deviation with respect to the Seafood HACCP regulation:
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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(b).
However, your firm does not have a HACCP plan for frozen whole round mackerel to control the food safety hazards of histamine formation and Clostridium botulinum growth and toxin formation. We acknowledge that your processing times are short and that histamine formation is unlikely during those steps; however, your firm should have a HACCP plan that lists a critical control point for receiving the fish that assures that the fish were handled in a safe manner aboard the harvest vessels. In addition, your firm should have a critical control point to assure that the packaging includes safe handling instructions to prevent the hazard of Clostridium botulinum growth and toxin formation while the product is sealed in the plastic bags (e.g., Keep Frozen, Thaw Under Refrigeration Immediately Prior to Use):
You should respond in writing within fifteen (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, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of five 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. You may view this alert at: http://www.accessdata.fda.gov/cms_ialialist.html.
Additionally, Section 743 ofthe 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 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 there-inspection and assessing and collecting there-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection- 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.
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 Part 110). You also have a responsibility to use procedures to prevent further violations ofthe Act and all applicable regulations.
Please send your reply to Food and Drug Administration, Attention: Arrna White, 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 Arma White via email at Arrna.White@fda.hhs.gov.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition