DEPARTMENT OF HEALTH & HUMAN SERVICES
March 5, 2012
VIA OVERNIGHT DELIVERY
Mr. Phillipe Charat, Owner
Maricultura Del Norte, S.De R.L.De C.V.
PO Box 850
Rancho Santa Fe, CA, 92067-0850
Reference No. 280237
Dear Mr. Charat:
On September 19 – 20, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood manufacturing facility, Maricultura Del Norte, S.De R.L.De C.V, located at Emiliano Zapata S/N Manzana I 51, Lote E1 Sauzal De Rodriguez, Esenada, Mexico. 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. We acknowledged receipt of your response provided via email on October 25, 2011. This response to the FDA 483 included a description of the corrective actions and additional supporting documentation, however no revised HACCP plan or plans were provided with the response. Our review of the documentation revealed that the response was not adequate, as further described in this letter. 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 blue-fin tuna appears to be adulterated, in that the products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or 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 note the following serious deviations from the requirements of the Seafood HACCP regulation:
You must 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(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 HACCP plan for blue-fin tuna does not list the food safety hazards of pathogen growth, parasite, or undeclared allergens. During the inspection, you indicated that your blue-fin tuna products may be used for raw consumption (i.e., sushi). Please refer to chapter to chapter 12 of the 4th Edition of the Hazard Guide for additional information related to the hazard of pathogen growth, chapter 5 for more information related to the hazard of parasites and chapter 19 for more information related to the hazard of undeclared allergens.
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 result be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s HACCP plan for refrigerated fresh tuna, collected during the inspection, does not list the critical control point of temporary storage for controlling the food safety hazard of histamine formation. We acknowledge your described correction, provided in your response; however your description is inadequate to control histamine. FDA recommends including temporary storage as critical control point in your revised HACCP plan to ensure the product temperatures are at or below 40°F.
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 response describes a critical limit that is not specific with regards to the acceptance level for decomposition. The proposed critical limit describes an “allowable percent of decomposition allowed in the lot, according to the requirements of the Fish and Fishery Products Hazards and Controls Guidance Fourth Edition.” FDA recommends a level of 2.5% decomposition in the lot, which means that your firm will accept the lot when 2 or fewer fish in a sample of 118 show signs of decomposition.Your specific target level should be included in your revised HACCP plan. In addition, the HACCP plan collected during the inspection fails to list an adequate critical limit for the fish held at the dock to ensure that temperatures are adequately maintained.Because the fish are held in totes, on ice, FDA recommends that the totes be monitored at the dock for adequacy of ice with a sufficient frequency to ensure adequate temperatures are maintained.
You must have a HACCP plan that, at a minimum, list monitoring procedures and frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for blue-fin tuna does not address the following:
- Your plan states that you will perform histamine testing; however, the plan does not specify how many fish you will test. Currently FDA recommends that when histamine testing is performed, a minimum of 18 fish in each lot is tested.
- Your plan states you will perform sensory evaluation; however, your plan does not list an adequate frequency for sampling. FDA recommends testing a minimum 118 fish, collected representatively throughout each lot (or the entire lot when there are fewer than 118 fish in the lot).
- Your plan states you will perform temperature monitoring; however, your plan does not include the number of fish to be sampled for temperatures at receipt. FDA recommends measuring a minimum of 12 fish, unless there are fewer than 12 fish in the lot, in which case you should measure the temperature of all of the fish.
Please respond in writing within thirty (30) working days from your receipt of this letter. Your response should include documentation, such as a revised HACCP plan and verification records, or other useful information that would assist us in evaluating your corrections. This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the current Good Manufacturing Practice regulations (21 CFR Part 11 0). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulation Please send your reply to the Food and Drug Administration, Attention: Maria Lau, Compliance Officer, CFSAN 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 Maria Lau by phone at (240) 402-2271 or via email at Maria.Lau@fda.hhs.gov.
Director Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition