Inspections, Compliance, Enforcement, and Criminal Investigations
Negocios Industriales Real "N.I.R.S.A.", S.A. 1/23/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
JAN 23, 2012
VIA OVERNIGHT MAIL
Mr. Roberto Aquirre Roman, President
Negocios Industriales Real "N.I.R.S.A.", S.A.
Avenida Plaza Danin s/n y Democracia
Reference No: 266736
Dear Mr. Roberto Aquirre Roman:
FDA inspected your seafood processing facility Negocios Industriales Real ''N.I.R.S.A.", S.A. located at Casilla 09-01-1269, Guayaquil, Ecuador, on August 8-10, 2011. During that inspection, we found that your firm had serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in FDA's issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection listing the deviations found at your firm.We acknowledge receipt of your responses to the FDA-483 received on August 24, 2011 and December 28, 2011. The responses included a revised HACCP plan for your canned tuna products. Our review revealed that the responses were not adequate, as further described in this letter.
In accordance with 21 CFR 123.6(g), failure of a processor offish 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 tuna is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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: 4th Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
Based on our review of the inspectional findings and the response documents, we find that you have the following serious deviations:
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 canned tuna does not list the following food safety hazards:
a. Your firm thaws frozen vacuum tuna loins, chunks, and flakes for approximately (b)(4) before filling the finished tuna product cans your HACCP plan does not list Clostridium botulinum growth and toxin formation as a hazard reasonably likely to occur.
b. Your firm uses a circular saw to remove the head and tail of fish weighing (b)(4) and your HACCP plan does not list metal inclusion as a hazard reasonably likely to occur.
c. Your firm uses soy flakes in the vegetable broth, which is listed as an ingredient in your firm's canned tuna products and your HACCP plan does not list the undeclared allergen of soy as a hazard reasonably likely to occur.
For additional information and guidance, please refer to Chapter 13, Chapter 19, and Chapter 20 of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
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 Canned Tuna provided in your December 28th response does not list the critical control points of Thawing, Cooling, and Pre-Cooking for controlling the food safety hazard of scombrotoxin (histamine) formation. Scombrotoxin formation is cumulative; consequently we suggest that your firm assess the total time and temperature exposures above refrigerated temperatures to determine the likelihood for excessive scombrotoxin formation at each of these steps. For example, as noted on page 142 of the 4th Edition of the Hazard Guide, for fish that have been frozen or heat processed in a manner sufficient to destroy scombrotoxin forming bacteria and where there is less likelihood for recontamination, FDA recommends that the fish not be exposed to ambient temperatures above 40° F (4.4° C) for more than 12 hours, cumulatively, if any portion of that time is at temperatures above 70° F (21.1°C). When no portion of that time is above 70° F (21.1 °C), FDA recommends that fish not be exposed to temperatures above 40° F (4.4° C) for more than 24 hours.
For additional information and guidance, please refer to Chapter 7 of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
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 listed in your HACCP provided in your December 28th response for Canned Tuna at the (b)(4) critical control point to control Scombrotoxin (histamine) formation is not appropriate. Your corrective actions of (b)(4) does not resolve how the cause of the deviation will be corrected.
In addition, your corrective actions plan in your canned tuna HACCP plan at the "Cleaning" critical control point to control Staphylococcus aureus growth and toxin formation is not appropriate. Your corrective action of "Sample the lot to determine presence/ absence of S. aureus. If presence is determined to reject the lot" does not resolve disposition of the affected product and correcting the cause of the process deviation.
Please refer to Chapter 12 of the Fish and Fisheries Products Hazards & Controls Guidance: Fourth Edition for additional information related to the hazard of Staphylococcus aureus growth and toxin formation and appropriate control strategies for your products.
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 include 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 any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty 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 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. This alert can be found on FDA's web site at: http://www.fda.gov/ora/fiars/ora_import_ia16120.html.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations (21 CFR Part 123), and the Current Good Manufacturing Practice regulation (21 CFR Part 11 0). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Leslie Hintz, Consumer Safety 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 any issue in this letter, you may contact Ms. Hintz at (240)402-2073 or via email at Leslie.Hintz@fda.hhs.gov.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition