DEPARTMENT OF HEALTH & HUMAN SERVICES
March 16, 2012
Mr. Giansandro Perotti
P.O. Box 13-05-4893
Reference No.: 283737
Dear Mr. Perotti: We inspected your seafood processing facility, Transmarina C.A., located at Via Circumvalacion, Sector 2, Km 9.5, Manta, Manabi, Ecuador on August 17-18, 2011. Upon further review of our investigator's inspection report and findings during the inspection, we determined that you have serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123.At the conclusion of the inspection, the FDA investigator issued a FDA-483, Inspectional Observations, listing the deviations found at your firm.
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 scombrotoxin (histamine) forming species of fish 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. You may find the Act and the Seafood HACCP regulation through links in FDA’s home page at www.fda.gov.
We acknowledge receipt of your response to the FDA 483 dated August 24, 2011, that included a HACCP plan dated 2011-08-18, as well as documentation reflecting histamine test data, grading of tuna pieces, process control tuna portions and process control tuna saku. However our review revealed that the response was not adequate, as further described in this letter. 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 entitled “Frozen and Hyper Frozen Fish Products” fails to include the food safety hazards Clostridium botulinum, and undeclared allergens.
With regard to allergens, HACCP plans need to include controls that assure that the finished product is appropriately labeled, which includes accurately declaring the packaged fish’s common and usual name.
Regarding Clostridium botulinum, hot sealing a plastic package creates conditions that may become anaerobic which promote Clostridium botulinum growth and toxin formation if the package is not properly thawed. FDA recommends that HACCP plans include controls that assure that the finished product labels contain a safe handling statement (e.g., “Important, keep frozen until used, thaw under refrigeration immediately before use”) 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(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 entitled “Frozen and Hyper Frozen Fish Products”, intended for your scombrotoxin (histamine) forming species of fish, lists critical limits that are not adequate, in association with the sensory portion to control histamine development.
The plan lists, b(4) at the Receiving critical control point. FDA recommends sensory examination of a representative sample of scombrotoxin-forming fish shows decomposition in less than 2.5% of the fish in the sample. For example, no more than 2 fish in a sample of 118 fish may show signs of decomposition. Furthermore, your method of sampling for sensory examination of, “for all pieces of fish, take a slice of the tail’s fish,” is not appropriate. FDA recommends collecting sample from the upper anterior of the fish for both sensory examination and histamine testing.
- Because you chose to include a corrective action plan in your HACCP plan, your described corrective action must be appropriate, to comply with 21 CFR 123.7(b). However your corrective action plan listed in your revised HACCP plan at the Receiving critical control point to control histamine (i.e., in the “Histamine testing” related portion of the critical control point) is not appropriate. It is not appropriate to resample (i.e. obtain additional samples from the lot).
Your firm's corrective action states, b(4) FDA recommends that when the histamine level exceeds your critical limit at the receiving step, that your corrective actions include either to, reject the lot, or to retest the individual fish from the original composited samples and reject the lot if the result is greater than 50 ppm.
For additional information regarding FDA’s recommended controls for the hazards and controls discussed above, please refer to Chapters 7 and 20 of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition, which can be found 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 and the Seafood HACCP regulation. 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.
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