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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Alimentos Prosalud, Sardimar 4/1/13


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

Public Health Service
Food and Drug Administration
 College Park, MD 20740 

 APR 1, 2013

Mr. Oscar Solano
Manufacturing Director
Alimentos Prosalud Sardimar
200 Metros Oeste De La Planta
Dos Pinos, Carretera Costanera
Puntarenas, Costa Rica
Reference No.: 394066
Dear Mr. Solano:
We inspected your seafood processing facility, Alimentos Prosalud Sardimar, located at 200 Metros Oeste De La Planta, Dos Pinos, Carretera Costanera, Puntarenas, Costa Rica, on, October 22-23, 2012. 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. 
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 canned sardines and tuna 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 Fish and Fisheries Products Hazards and Controls Guidance through links in FDA’s home page at www.fda.gov.
We acknowledge your firm’s email response dated November 13, 2012, to the FDA-483. In your response, your firm provided incomplete portions of HACCP plans that appear to be revised to include corrective actions in response to the FDA-483. As noted in our concluding paragraph, your firm should submit complete copies of your revised HACCP plans for both your canned tuna and canned sardines along with copies of monitoring records. Further, your response did not address all of the concerns identified during the inspection.  Consequently, we continue to have concerns with your seafood HACCP program for your canned sardines and canned tuna products, as further described in this letter.
Your significant violations were 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 as 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 plans collected during the inspection for your canned sardines and canned tuna products do not list critical control points (CCP) from thawing of the fish to the final retort operation. 
Our investigation revealed that none of the processing steps are conducted at temperatures at or (b)(4).  Consequently, there is a potential for the hazards of histamine and pathogen growth and toxin formation in the canned sardines and canned tuna products. These steps may include thawing, misting, cooling, in-process refrigerated storage, cleaning, heading/gutting, filleting/boning, loining, racking, and other pre-canning steps.
In addition, our investigator noted during the inspection that your firm conducts thawing processes for (b)(4) at ambient water temperatures (b)(4) and that your firm also uses (b)(4) for (b)(4) to expedite the thawing process. FDA recommends that fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 4 hours, cumulatively, if any portion of that time exceeds 70°F (21.1°C). 
Moreover, a histamine study, such as the one provided with your corrective action plan, does not replace controls that should be established to control food safety hazards when time and temperatures are exceeded. There are several ways in which a firm may be able to control these hazards. For example, FDA recommends controlling exposure to temperatures through monitoring time and ambient temperatures of the processing step to control histamine formation and pathogen growth. Additionally, we were unable to fully evaluate the study since you did not supply the original data and laboratory results.
  • 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 plans for canned sardines and canned tuna do not list the food safety hazard of undeclared allergens. As a control strategy, FDA recommends including a CCP to ensure that your finished products are accurately labeled to declare all allergenic substances. 
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. Your response should include documentation, such as a copy of any revised HACCP plan or plans; at least five (5) completed production days worth of monitoring records to demonstrate that you have implemented the revised plan or plans; any verification records; and any other useful information that would assist us in evaluating your corrections.  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
During our assessment, we noted another item that we are bringing to your attention.  While your corrective action plan at the receiving CCP has identified a critical limit for histamine at (b)(4), FDA recommends setting the critical limit at ≤50ppm as the guidance level for histamine. In addition, this critical limit value is adequate only when testing individual fish samples. When compositing samples, the limit should be reduced accordingly. For example, if your firm uses six (6) samples of three (3) fish composited, then the critical limit should be reduced to ≤17ppm.
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 US Agent.
Please send your reply to the U. S. Food and Drug Administration, Attention: Donald W Greaves, 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 any issue in this letter, you may contact Mr. Greaves at (240) 402-2057 or via email at Donald.greaves@fda.hhs.gov.
Roberta Wagner
Office of Compliance
Center for Food Safety
    and Applied Nutrition