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  5. BRODR. REMO AS - 447646 - 03/04/2015
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WARNING LETTER

BRODR. REMO AS MARCS-CMS 447646 — 04/03/2015

BRODR. REMO AS - 447646 - 03/04/2015


Recipient:
BRODR. REMO AS


United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

 

WARNING LETTER
MAR 4, 2015 
 
VIA EXPRESS DELIVERY
 
 
Johnny A. Remo, Managing Director
Brodr Remo A.S.
Davidsplass 1
6035 Fiskarstrand,
Norway
 
Reference # 447646  
 
Dear Mr. Remo:
 
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility Brodr Remo A.S. located at Davidsplass 1, 6035 Fiskarstrand, Norwayon August 29 through September 1, 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 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 receipt of your response sent via emails on September 16 and 17, 2014. Your responses included various documents including a revised HACCP plan dated September 9, 2014 for your vacuum packaged cold smoked salmon and trout, as well as descriptions of your corrections to the FDA 483 and additional supporting documentation. However, review 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 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 vacuum packaged cold smoked salmon and trout 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/GuidanceDocumentsRegulatoryInformat….
 
Your significant deviations are as follows:
  1. 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 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 21 CFR Part 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 revised HACCP plan for your vacuum packaged cold smoked salmon and trout provided with your September 17th response does not list the food safety hazard of unapproved aquaculture drugs (i.e., drugs that are unapproved for use on fish destined for the U.S. marketplace).
  1. 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 revised HACCP plan for your vacuum packaged cold smoked salmon and trout provided with your September 17th response does not list the critical control points for cold storage after receiving (referenced in your flow chart as step “2. (b)(4). For cold storage of fish observed to be (b)(4), FDA recommends that your HACCP plan list a critical control point with a critical limit that ensures product is completely surrounded by ice throughout storage with visual observations of the adequacy of ice from a representative number of containers throughout the cooler. For cold storage of fish that were observed to be held on racks in a cooler after cold smoking, FDA recommends that your HACCP plan list a critical control point that ensures the product is maintained at 40°F (4.4°C) or below with continuous ambient temperature monitoring.
  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 for your vacuum packaged cold smoked salmon and trout provided with your September 17th response lists critical limits at the following critical control points that are not adequate to control Staphylococcus aureus and Clostridium botulinum toxin formation.
    1. At the “(b)(4)” critical control point, your HACCP plan lists critical limits of “Always use eviscerated fish to process. From fish out of the box, to make the (b)(4).” However, these time and temperature parameters do not adequately control Staphylococcus aureus growth and toxin formation, FDA recommends when the product is held at internal temperatures between 50°F (10°C) and 70°F (21.1°C) that the exposure time at internal temperatures should be limited to 12 hours. When using temperature-indicating devices and clocks, the internal temperature of the fillets should be monitored at least every two hours and the length of time above 50°F (10°C) should be monitored for each batch. If at any time the product is held at internal temperatures above 70°F (21.1°C) during the salting and maturation step the exposure time should be limited to 3 hours. PLEASE NOTE: The cumulative exposure time at internal temperatures above 50°F (10°C) during maturation includes the exposure time at the “CCP-1 6A Salting and maturation for cold smoking” critical control point and the exposure time at the “CCP-2 7A Cold smoking” critical control point (prior to the addition of cold smoke).
    1. At the “(b)(4).” To control S. aureus toxin formation, FDA recommends that when  product is held at internal temperatures between 50°F (10°C) and 70°F (21.1°C) the exposure time at internal temperatures above 50°F (10°C) should be limited to 12 hours. If using temperature-indicating devices and clocks, the internal temperature of the fillets should be monitored at least every two hours and the length of time above 50°F (10°C) should be monitored for each batch. If at any time the product is held at internal temperatures above 70°F (21.1°C) during the salting and maturation step(s), the exposure time at internal temperatures above 50°F (10°C) should be limited to 3 hours. PLEASE NOTE: The cumulative exposure time at internal temperatures above 50°F (10°C) during maturation includes the exposure time at the “CCP-1 6A Salting and maturation for cold smoking” critical control point and the exposure time at the “CCP-2 7A Cold smoking” critical control point (prior to the addition of cold smoke).
    1. At the “(b)(4)”to control Clostridium botulinum toxin formation. FDA recommends that finished product is held at cooler temperatures of 40ºF (4.4ºC) or below. The temperature of cooler should be continuously monitored using a continuous temperature-recording device (e.g., a recording thermometer), with a visual check of the recorded data at least once per day
  
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, 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. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
 
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 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.
 
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.
 
Please send your reply to Food and Drug Administration, Attention:  Philip Bermel, 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 Mr. Bermel via email at Philip.Bermel@fda.hhs.gov.
 
Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety   
   and Applied Nutrition

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