DEPARTMENT OF HEALTH & HUMAN SERVICES
March 13, 2012
VIA OVERNIGHT DELIVERY
Mr. Robert Campbell-Preston,
Taynuilt, Argyll, PA35 1HU,
Reference No.: 264695
Dear Mr. Campbell-Preston:
On September 28 and 29, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood manufacturing facility, Inverawe Smokehouses, located at Taynuilt, Argyll, PA35 1HU, Scotland, UK. 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.
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 smoked fishery products appear to be adulterated, in that the products have been prepared, packed, or held under insanitary conditions 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.
We acknowledged receipt of your response provided on October 7, 2011. This response to the FDA 483 included revised HACCP plans for Trim cold smoked Salmon and Trout and Kippers as well as several record logs. Our review revealed that the response was not adequate, as described below.
We note the following serious deviations from the requirements of the Seafood HACCP regulation:
You must have a HACCP plan that, at a minimum, lists a critical limit 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 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 firms revised HACCP plans for Kipper and Trim Cold Smoked Salmon & Trout provided in your response do not list adequate critical limits at the following critical control points (CCP):
At the “Receiving” CCP, your critical limit of “temperature on receipt of fish no b(4) is not adequate because taking a one time temperature at receipt is only adequate when the transport times are short, for example less than 4 hours. However, your firm receives some products that are in transit for extended time periods (i.e., greater than 4 hours).
For those products that are in transit for less than 4 hours, your plan should include a critical limit that includes assurances limiting the time of transport to 4 hours.
For those products that are in transport longer than 4 hours, your firm should implement a system that provides assurance that the fish were transported under safe conditions for the duration of the transit period (e.g. monitoring the adequacy of ice or requiring continuous time and temperature monitoring).
At the “Brining” critical control point.
The plan lists your critical limit for salt as b(4) brine tub. Your firm has a dry salting operation and a specific procedure for layering the fish in the salting tubs. This should be referenced in the plan since these are for achieving the necessary salt content in all of the fish in the lot. Your firm may either cross reference your dry salting procedures in the HACCP plan or list the procedures in the plan.
The plan fails to list a critical limit for temperature. Our investigator was told during the inspection that the brining process may take up to 90 minutes; therefore, temperatures should be monitored to control pathogen growth and toxin formation including the potential for Staphylococcus aureus. FDA recommends a critical limit of 10ºC.
At the “Smoking” CCP, the plan fails to list a critical limit for processing time. The length of the process necessary to achieve the targeted water activity (Aw) or water phase salt (WPS) should be included in the plan. The process currently lists a sensory evaluation of the end product, which does not provide a safety assurance equivalent to process controls.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act and the applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
You should respond in writing within thirty (30) 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 that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Carol D’lima, Office of Compliance, Division of Enforcement, Food Assessment Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. D’lima at (240) 402-2033 or via email at firstname.lastname@example.org.
Jennifer A. Thomas.
Division of Enforcement
Office of Compliance
and Applied Nutrition