DEPARTMENT OF HEALTH & HUMAN SERVICES
March 22, 2012
Mr. James Gallagher
Scottish Sea Farms, Ltd.
Laurel House, Laurel Hill Business Park, Polmaise Road
FK7 9JQ Scotland, United Kingdom
Reference No.: 288277
Dear Mr. Gallagher:
We inspected your seafood processing facility, Scottish Sea Farms Ltd., located at South Shian, Connel, Argyll PA37 1SB, Scotland, United Kingdom, on September 26-27, 2011. During that inspection, we found that you had 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.
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 firm’s aquaculture farmed salmon appear to be adulterated, in that the products have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.At the conclusion of the inspection, the FDA investigator issued a FDA-483, Inspectional Observations, listing the deviations found at your firm.
We acknowledge receipt of your response to the FDA-483 on January 31, 2012, that included your revised HACCP plan dated October 27, 2011, pre-startup blank monitoring record, blank processing HACCP checklist and photographs.Our review found that the response was not adequate, as further described in this letter.
You may find the Act and the Seafood HACCP regulation through links in FDA’s home page at www.fda.gov.
We note the following serious deviations from the requirements of 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(a) and (b).However, your firm’s HACCP plan for aquaculture-farmed salmon does not list the food safety hazard of undeclared allergens.Since finfish are considered one of the eight common allergens, you should have controls in place to ensure that all packages contain the common or usual name of the fish to inform consumers.
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(a)(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 Manual 2 dated 27/10/11 lists critical limits at CCP 1, “specific period for drug” and “analysis completed” that are not adequate.
Since your firm occasionally buys salmon from other suppliers, FDA recommends that you have two sets of critical limits:
For your own farms:
Your critical limit of “specific period of drug” should include the specific drug usage.FDA recommends that your firm monitor records of on-farm drug, visually, every lot to ensure that drugs are used in accordance with FDA regulations.
Your critical limit of “analysis completed”, in your plan should specify the limit of the residue level of the drugs to ensure that the fish do not exceed FDA’s tolerance for that drug.FDA recommends that analysis be performed at a frequency of every lot.
For receipt of fish from outside suppliers' farms:
- In addition to the recommendations above, your supplier’s critical limit should include that only drugs approved by FDA are used.FDA recommends adding the following guidance for verification; your firm to periodically take samples at receiving from your suppliers and test for antibiotics, visit the farms to observe the growing period, and verify the drugs that are used.
In addition, your firm should consider whether pathogen growth and toxin formation due to time/temperature abuse, if the product is to be consumed raw without further controls being applied, should be addressed as a potential hazard.
For additional information regarding FDA’s recommended controls for the hazards and controls discussed above, please refer to Chapters 11, 12 and 19 of the Fish and Fisheries Products Hazards and Controls Guidance:Fourth Edition, which can be found on FDA’s web site at: www.fda.gov.The Seafood HACCP guide is on FDA's website at:
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.You should include in your response documentation such as a copy of any revised HACCP plans, at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan and other useful information that would assist us in evaluating your corrections.If you cannot complete all corrections before the 30 days, you should explain the reason for your delay and state when you will correct any remaining violations.
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, 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:Standra Purnell, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A.If you have any questions regarding this letter, you may contact Standra Purnell via email at firstname.lastname@example.org.
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition