DEPARTMENT OF HEALTH & HUMAN SERVICES
April 10, 2012
VIA OVERNIGHT DELIVERY
Ms. Jeannette Oyarzun Perez
Plant Assistant Manager
Panamericana Sur Km 1030
P.O. Box 10D
Puerto Montt, Chile
Dear Ms. Perez:
We inspected your seafood processing facility, Comsur Ltda., located at Panamericana Sur Km 1030, P.O. Box 10D, Puerto Montt, Chile on November 4-5, 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 and the Current Good Manufacturing Practice.
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 and trout appear to be adulterated, in that the products have been prepared, packed, or held under 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, dated November 15, 2011 and additional correspondence on March 22, 2012 that included your Quality Assurance Plan and photographs. However our review revealed that your 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 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 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 aquaculture farmed salmon and trout 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 packages contain the common or usual name of the fish to inform sensitive consumers. Refer to Chapter 19 of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition (the Guide), “Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives,” for guidance to control this hazard.
- You must have a HACCP plan, that at a minimum lists the critical control points, to comply with 21 CFR 123.6(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 aquaculture farmed salmon and trout currently lists “Vacuum Sealing” as an “(Optional)” critical control point. When a particular control point is necessary for preventing or reducing to an acceptable level any food hazard that is reasonably likely to occur, firms must include an adequate critical control point (i.e., as mandatory for that product). Consequently, this critical control point, which is necessary for control of Clostridium botulinum and which you include as a hazard with a control method of labeling with the statements “Freezing and thawing under refrigeration” will need to be included in your HACCP plan as mandatory, not optional. For further guidance to ensure your critical limit, monitoring, corrective actions, record keeping and verification are adequate you should refer to Chapter 13 of the Guide.
- 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 does not list a critical limit adequate to control the food safety hazard of unapproved aquaculture drugs (i.e., use of aquaculture drugs unapproved for use in fish destined for the U.S. market). The letter of guarantee used as your monitoring strategy should reference proper drug use and should accompany each incoming lot of fish. Subsequently, your monitoring, corrective actions, record keeping and verification should be modified and updated to ensure adequacy throughout your plan. For further guidance refer to Chapter 11 of the Guide.
For additional information regarding FDA’s recommended controls for the hazards and controls discussed above, the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition, can be found on FDA’s web site 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. Your response should include 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, Consumer Safety 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