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  5. Sociedad Guidomar Ltda - 11/24/2014
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Sociedad Guidomar Ltda

Sociedad Guidomar Ltda

United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


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

Public Health Service
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740


November 24, 2014
Guillermo Donoso Tobar
General Manager
Sociedad Guidomar Ltda
Libertad Numero 19
Coquimbo, Chile
Reference No. # 442174
Dear Mr. Tobar:
We inspected your seafood processing facility Sociedad Guidomar Ltda located at Libertad Numero 19 Coquimbo, Chile on May 22-23, 2014. During that inspection, we found you had serious violations of 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 acknowledge receipt of your response sent via email on June 2, 2014. Your response included various documents, including a written statement of corrections, revised HACCP plan in Spanish, and other supporting documents. Additionally, you provided your revised HACCP plan in English via email on August 1, 2014.  However, review of your revised HACCP plan revealed serious deviations, 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 frozen, cooked crustaceans (i.e. langostino tailmeat and shrimp) 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, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, 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:
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 (Version 14) for your cooked crustaceans does not list the following critical control point(s) to control the food safety hazard of pathogenic bacteria growth and toxin formation.
a.    Your HACCP plan does not list refrigerated storage as a critical control point following the cook step to control post-cook contamination. Your operational steps for your cooked crustaceans states “Optionally, the cooled product will remain in trays with ice, before it entry to tail removing (maintenance area), for a period (b)(4). Since this time period is extensive, FDA recommends you include the storage period as a critical control point to ensure that proper time and temperature controls are maintained to control the hazard of pathogenic bacteria growth and toxin formation.
b.    Your HACCP plan does not list all processing steps that follow the cook step, as one cumulative critical control point or as multiple individual critical control points to control post-cook contamination. Your flow chart for cooked crustaceans and your description of the operational steps describes processing steps (b)(4) where handling occurs following the cook step, prior to freezing. Consequently, post-cook contamination with pathogenic bacteria is a reasonably likely hazard. Therefore, FDA recommends you establish appropriate time and temperature controls during all of these steps.
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 revised HACCP plan (Version 14) for your cooked crustaceans lists the following inadequate critical limits that are not adequate to control the hazard of pathogenic bacteria growth and toxin formation.
a.    Your critical limit at the “Cooling” critical control point lists “(b)(4)”. Since your cooked crustaceans are significantly handled after cooking, FDA recommends cooling the products to an internal temperature below 21.1°C within 1 hour, and limiting exposure times to temperatures between 21.1°C and 10°C to 3 hours.
b.    Your critical limit at the “(b)(4)”. Since your firm handles the cooked shrimp at this critical control point and the temperature is listed between 21.1°C and 10°C, FDA recommends you include the time held during this critical control point as part of the total cumulative time exposures prior to freezing.
3.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP plan (Version 14) for your cooked crustaceans, lists a monitoring procedure/frequency at the “Cooking” critical control point that is not adequate to control pathogenic bacteria survival through the cooking process. Your monitoring procedure states that you (b)(4) and at the beginning of cooking. FDA recommends using a continuous temperature-recording device to measure the temperature of the cooking equipment at the cold spot of the equipment, and a visual observation of temperature at least once per day.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or 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 implementation of the 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 is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html
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 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.
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 Food and Drug Administration, Attention:  Sheena Crutchfield, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Crutchfield via email at sheena.crutchfield@fda.hhs.gov.
William A. Correll
Office of Compliance
Center for Food Safety
    and Applied Nutrition
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