Seafood Processing - Mardex, S.A.


February 16, 2012

Mr. Otto Schwartz
Mardex, S.A.
P.O. Box 13053894
Manta, Ecuador

Re:  277500

Dear Mr. Schwartz:

We inspected your seafood processing facility, Mardex, S.A., located at Avenida 102, Los Esteros, Manta, Manabi, Ecuador on August 19-24, 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 (21 CFR 123).

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 tuna, marlin, mahi-mahi, wahoo, and escolar products appear to be adulterated, in that the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. 

We acknowledge receipt of your response received via email on August 30, 2011.  This response to the FDA 483 that was issued to your firm at the conclusion of the inspection included a revised HACCP plan as well as additional supporting documentation.  However our review of the documentation revealed 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

We note the following serious deviations from the requirements of the Seafood HACCP regulation:

  1. 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 for fishery products does not list the following:

    • A critical control point for receiving for controlling the food safety hazard of histamine when your firm receives the fish in transit after it arrives from the port where the fish are off-loaded from the boats.  Specifically, your firm is not located in close proximity to the port where the fish are off-loaded.  Consequently, your firm needs to have a separate receiving critical control point for receiving fish from the port. 

      We acknowledge that your HACCP plan includes controls associated with your firm as a primary processor, i.e., the first processor to take possession of the fish after off-loading from the boats.  However, because your firm is not located near to port, your firm needs to ensure that the fish were both properly handled on board the boats and during transit to your facility from the port.  For example, your firm should monitor the internal temperature of the fish at off-loading to ensure that the fish were adequately chilled aboard the vessel.  In addition, because the fish are in transit for an extended time period from the port to your facility, your firm should monitor temperatures or transport conditions upon receipt at your plant to ensure that the fish were well chilled from the boat to your facility.  In summary, FDA recommends two receiving critical control points for a facility such as yours, one at the vessel/port and one at the facility since the fish are transported for a significant period of time.

    • A critical control point for the carbon monoxide (CO) treatment.  The products are CO treated and held for up to 48 hours during this the treatment.  This poses a hazard for both histamine development and Clostridium botulinum toxin formation, in the absence of temperature controls.
  2. 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 HACCP plan lists a critical limit                                                                                                b(4)  at the receiving critical control point that is not adequate to control histamine.  FDA recommends that no more than 2 fish in a sample of 118 fish may show signs of decomposition.

  3. 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 for histamine-forming fish at the reception and refrigerated storage critical control points to control histamine is not appropriate.  Specifically,

    • When your critical limit for decomposition is exceeded during sensory analysis, your plan lists that your firm will dispose of spoiled fish and conduct further histamine testing on a                                   b(4) throughout the lot.  However, your corrective action should also include that if histamine is greater than 50 ppm in any sample, the lot entire will be rejected. In addition, FDA recommends that you include and take remedial steps, such as chilling and holding the affected lot until histamine analysis is performed.;

    • At your “Refrigerated Storage of Raw material and In Process fish (CO treated)” CCP, you list that you will take a corrective action for products                      b(4).  Your firm has no monitoring temperatures at this critical control point, consequently, your firm will be unable to implement this action.  Furthermore, your corrective action of “perform histamine analysis in a sample of                      b(4).  If histamine is found to be greater than 50 ppm divert any fish above for animal food use or destroy it” is inadequate.  The current corrective action implies that only the fish with histamine greater than 50 ppm will be destroyed.  FDA recommends that your corrective action be clarified to state that you will destroy the entire lot or divert it into a non-food use if any fish is found with histamine greater than or equal to 50ppm.  

For additional information regarding FDA’s recommended controls for the hazards and controls discussed above, please refer to Chapters 7, 13, 19 and 20 of the Fish and Fisheries Products Hazards and Controls Guidance:  Fourth Edition, which 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 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, Manufacturing and Storage Adulteration 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



Jennifer Thomas
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition

Page Last Updated: 07/03/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English