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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Good Fish 8/19/13


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD 


AUG 19 2013
Sixto De Souza N.
Gerente General
Joanquin Mancheno N75-38
Avenida Jose Andrade
Quito, Pichincha
                                                            Re: 408770
Dear Mr. DeSouza N.:
We conducted an inspection of your manufacturing facility located at Joanquin Mancheno N75-38  Avenida Jose Andrade, Quito, Pichincha, Ecuador on March 4 and 5, 2013. During that inspection, we found that you have 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 regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 and 110). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the observations noted during the inspection.
We acknowledge receipt of your response sent via email on April 24, 2013. Your response included several documents, such as the results of histamine testing performed at your firm, a Hazard Analysis document, a HACCP Plan entitled ((b)(4), a HACCP manual entitled (b)(4), a copy of your corrective action record template, and a copy of your organoleptic analysis template.   However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
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 fresh fish fillet products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.  
The Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Your significant deviations are as follows:
  • You must conduct a hazard analysis 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 critical control points, to comply with 21 CFR 123.6(a) and (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 provided in your response dated 4/24/2013 for your vacuum packed fresh fish fillets (mahi-mahi and other histamine forming fish) does not list the critical control point of cooler storage for controlling the food safety hazard of histamine formation. Specifically, your revised HACCP plan does not list (b)(4) as a critical control point (CCP). Your HACCP manual “(b)(4)” states on page 10 that this product can remain in the cooler for up to three days following washing and weighing.
  • 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 for vacuum packed fishprovided in your response lists a critical limit of (b)(4) at the receiving critical control point associated with the internal temperature monitoring parameter that is not adequate to control histamine formation. FDA recommends a critical limit of 4.4˚ C to control histamine formation at receiving for primary processors conducting histamine testing at receipt of the fish from the harvest vessels.
  • You must implement the procedures that you have listed in your HACCP plan to comply with 21 CFR 123.6(b). However, your firm did not follow the procedure of utilizing oxygen permeable vacuum packaging at the bagging critical control point to control Clostridium botulinumgermination, growth and toxin formation listed in your HACCP plan for fresh vacuum packed fillets. The packaging material used in your (b)(4); however, this is insufficient to prevent C. botulinum growth and toxin formation. 
Should your firm choose to continue to use your current packaging, FDA recommends that time and temperature indicators (TTIs) be affixed to each individual sealed package of fish so that end users can determine if the packages have been exposed to times and temperatures that can lead to the C. botulinum germination, growth and toxin formation before the product reaches the end user. An alternate way to control C. botulinum in raw vacuum packaged fish is to freeze and distribute frozen vacuum packaged product that is individually labeled with “Important, keep frozen until used, thaw under refrigeration immediately before use.”
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation that would assist us in evaluating your corrections, such as a copy of any revised HACCP plans; five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate that you have implemented the revised plan or plans; and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations. Submission of the information in English will assist in our review. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action.  For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation [21 CFR Part 123] is Import Alert #16-120. This alert can be found on FDA’s web site at: 
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 all applicable regulations, including the Seafood HACCP regulation and the current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Additionally, Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. 
The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.  Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the Food and Drug Administration, Attention:  Leonora Darlington, 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 Ms. Darlington via email at Leonora.Darlington@fda.hhs.gov 
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition