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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Nicalapia S.A. 5/30/12

  

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

Public Health Service
Food and Drug Administration
 

College Park, MD 20740

MAY 30, 2012

WARNING LETTER

VIA EXPRESS DELIVERY

Xavier I. Sanchez
General Manager
Nicalapia S.A.
Km 341/2 Carretera Nueva A Leon
Frente a cementeria Hocim
Leon, Nicaragua

Re: 302378

Dear Mr. Sanchez:

This letter is in response to the information and documentation your firm provided on April 9, 2012, in response to our letter to your firm dated January 31, 2012. Our January 31st letter detailed serious concerns that we found during an inspection of your facility conducted on August 15-16, 2011. 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 a form FDA-483, lnspectional 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 scombrotoxin (histamine) forming fish 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 & Controls Guidance through links in FDA's home page at www.fda.gov.

The 4th Edition of the Hazards Guide can be found at our web site at:

http://www.fda.gov/Food/GuidanceComplianceRegulatoryinformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/index.htm

Based on the information provided in your April 9th correspondence, we note the following serious deviations:

1. 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 "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 plans for "Frozen", "Fresh Whole Fish Headless" and "Frozen Fish Fillet Histamine" list critical limits that are inadequate at the Receipt of Raw Material critical control point to control histamine. The revised HACCP plans included with your response received April 9, 2012 list:

a. For "Decomposition," a critical limit of no more than (b)(4) decomposition persistent and perceptible. FDA recommends sensory examination of a representative sample of scombrotoxin forming fish that shows decomposition in less than 2.5 % of the fish in the sample. For example, no more than 2 fish in a sample of 118 fish may show signs of decomposition.

b. For the internal temperature step, your plans do not include critical limits associated with the number of fish to be sampled for internal temperature. FDA recommends measuring a minimum of 12 fish, unless there are fewer than 12 fish in the lot, in which case all the fish should be measured. In addition, FDA recommends taking the internal temperature of a representative number of the largest fish in the lot at the time of off-loading, concentrating on any fish showing signs of being mishandled and monitoring the date and time of off-loading.

2. You must have a HACCP plan that, at a minimum, "lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's revised HACCP plans for "Frozen," ''Fresh Whole Fish Headless," and "Frozen Fish Fillet Histamine" list monitoring procedures and frequencies at Receipt of Raw Material critical control point that are not adequate. Specifically,

a. For the decomposition step, your plans list This (b)(4) is not adequate because it does not include to analyze. FDA recommends that firms examine at least 118 fish, collected representatively throughout each lot (or the entire lot, for lots smaller than 118 fish).

b. For the histamine analysis step, your plans list (b)(4). This is not adequate because there is no information 1 to the histamine testing strategy. FDA recommends that firms include information about the testing method; the collection procedures; and the number of fish to be tested (for example, a minimum of 18 fish, collected representatively throughout each lot (or the entire lot when there are fewer than 18 fish in. the lot)). Each lot should consist of a single species of fish.

3. Because your firm chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for "Frozen," "fresh Whole Fish Headless," and "Frozen Fish Fillet Histamine" at the Receipt of Raw Material critical control point are not adequate.

a. For the internal temperature step, your plans state (b)(4). This is not adequate because the subset of fish examined for the internal temperature critical control point at receiving should be used to reflect the temperatures of the entire lot. Thus culling out individual fish that have exceeded the temperature critical limit is not recommended.

FDA recommends your corrective actions for product involved in a critical limit deviation for internal temperature include: chilling and holding the product until it can be evaluated based on its total time and temperature exposure, including exposures throughout all processing operations or chilling and holding the affected product until histamine testing is performed on a minimum of 60 fish collected throughout each affected lot and rejecting that lot if any fish are found to contain histamine greater than 50 ppm or destroying the lot or diverting the product to a non-food use.

b. For the sensory examination step, your plans state (b)(4). Culling individual fish and (b)(4) those individual fish that do not meet the sensory exam is not adequate because the fish evaluated at the sensory critical limit at receiving should be used to reflect the condition of the entire lot. FDA recommends chilling and holding the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected throughout the lot, including all fish in the lot that show evidence of decomposition (persistent and readily perceptible odors) (or the entire lot for lots smaller than 60 fish. FDA further recommends rejecting the lot if any fish are found with histamine greater than or equal to 50 ppm, taking corrective actions to regain control over the operation after a critical limit deviation, and addressing the root cause.

c. For the histamine testing steps, your plans states (b)(4). This is not adequate because the histamine testing strategy to reflect the condition of the entire lot. FDA recommends that firms reject the lot when the histamine level critical limit at the receiving step has not been met.

4. 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 revised HACCP plans for "Frozen," "Fresh Whole Fish Headless," and "Frozen Fish Fillet Histamine" do not list the food safety hazard of undeclared allergens.

Since finfish are considered one of the eight common allergens, you should have controls in place to ensure packages contain the common or usual name of the fish to inform sensitive consumers. Refer to Chapter 19 of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition (the Guide), "Undeclared Major Food Allergens and Certain Foods Intolerance Causing Substances and Prohibited Food and Color Additives," for guidance to control this hazard.

For additional information regarding the hazards and controls discussed above, please refer to the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition, can be found on FDA's web site at:
http://www.fda.gov/Food/GuidanceComplianceRegulatoryinformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/index.htm

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. You should include in your response 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, any verification records, 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.

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. This procedure is generally based on past history or other information, such as an inspection of a facility or HACCP plan review, indicating that the factory producing the product or the product itself may not be in compliance with FDA's laws and regulations. DWPE information is conveyed in FDA's Import Alerts. 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: http://www.fda.gov/ora/fiars/ora_import_ia 16120.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, 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, 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 Standra Purnell by phone at (240) 402-1613 or via email at standra.pumell@fda.hhs.gov.

Sincerely,

/S/

Michael Roosevelt
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition