Inspections, Compliance, Enforcement, and Criminal Investigations
Comercial Comtesa S.A. 12/13/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20742
December 13, 2013
VIA EXPRESS DELIVERY
Quality Assurance Manager
Comercial Comtesa S.A.
Lautaro Navarro 1398
Punta Arenas, Chile
Reference No. # 413796
Dear Mr. Rodas:
We inspected your seafood processing facility Comercial Comtesa S.A. located at Lautaro Navarro 1398, Punta Arenas, Chile on May 6-7, 2013. During that inspection, we found that 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. At the end of the inspection, you promised to make corrections, and on November 5, 2013, via phone and email, you agreed to submit a revised HACCP plan; however, to date we have not received a response. Our review of the HACCP plan collected during the inspection 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 vacuum-packaged wild caught centolla (king) and centollon (queen or snow) crabmeat 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:
1. 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 HACCP plan for “(b)(4)” does not identify the food safety hazard of Clostridium Botulinum growth and toxin formation.
Packaging conditions that reduce the amount of oxygen present in the package, such as vacuum packaging, increases the potential for C. botulinum growth and toxin formation. Therefore, FDA recommends your frozen vacuum-packaged finished products contain a label with statements such as “keep frozen,” and “Important, keep frozen until used, thaw under refrigeration immediately before use.”
2. 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 HACCP plan for “(b)(4)” does not list the following critical control points for controlling the food safety hazard of pathogenic bacteria growth.
a. Your HACCP plan does not list unrefrigerated processing as a critical control point. Our investigator observed your firm handling the crab in unrefrigerated processing areas following the cook step, prior to final freezing. Consequently, post-cook contamination with pathogenic bacteria is a reasonably likely hazard. Your firm needs to establish appropriate time and temperature controls.
b. Your HACCP plan does not list refrigerated storage as a critical control point. Our inspection revealed that your firm stores the crab in a cooler that is kept (b)(4). FDA recommends that you include all storage periods as critical control points to ensure that proper time and temperature controls are maintained to control the hazard of pathogenic bacteria growth.
3. 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 for “(b)(4)” lists critical limits that are not adequate to control pathogenic bacteria growth.
a. Your critical limit at the “(b)(4).” To fully control the hazard of pathogenic bacteria growth, FDA recommends the critical limit for cooking include all of the following:
i. length of cook (speed of the belt for a continuous cooker)
ii. temperature of water used for cooking
iii. initial temperature of the product
iv. maximum cooker load
b. Your critical limit at the “(b)(4).” To control the hazard of pathogenic bacteria growth, FDA recommends the product be cooled from 135°F (57.2°C) to 70°F (21.1°C) within 2 hours, and from 135°F (57.2°C) to 40°F (4.4°C) within an additional 4 hours. You may also want to consider conducting a cooling rate study to establish minimum or maximum values for the critical factors of the process that affect the rate of cooling; for example, product internal temperature at the start of cooling, quantity of ice, quantity or size of the product being cooled.
4. 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 HACCP plan for “(b)(4)” lists a monitoring procedure/frequency at the “(b)(4)” critical control point that is not adequate to control pathogenic bacteria growth.
Your monitoring procedure states that you will conduct a “(b)(4).” 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 the start and end of each cooking cycle.
5. Predetermined corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). However, your corrective action plan for “(b)(4)” list inadequate corrective actions.
a. Your corrective action plan for the “(b)(4)” critical control point does not address how you will regain control over your cooking operation after a critical limit deviation. Your actions only address disposition of the product, but does not include how your firm will correct the cause of the critical limit deviation.
b. Your corrective action plan for the “(b)(4)” critical control point does not ensure that adulterated product does not enter into U.S. commerce. Your actions indicate that your firm (b)(4). FDA recommends recooking the product, destroying the product or diverting the product to a non-food use.
You should respond in writing within 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, 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. Sheena Crutchfield via email at firstname.lastname@example.org.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition