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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Peslasa S.A. 8/19/10


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

Public Health Service
Food and Drug Administration
 College Park, MD

Warning Letter
I.D. # 126092

August 19, 2010        


Jorge Franco, General Manager/Owner
Peslasa SA
Robles 401 y Estrada Coello
Guyaquil, Ecuador

Dear Mr. Franco:

We inspected your seafood processing facility, located at Robles 401 y Estrada Coello, Guyaquil, Ecuador on May 13 through 14, 2010.  We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and  the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110  (21 CFR 123 & 110).  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 moonfish and other scombrotoxin (histamine) forming fish are adulterated, in that they have been prepared, packed, or held under insanitary 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.

Your significant violations were as follows:

1. You must implement the monitoring procedures and frequencies that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b).  However, you did not implement the monitoring procedures and frequencies listed at the Reception Fresh Fish critical control point in your HACCP plan for frozen headed and gutted scombrotoxin (histamine) forming fish to control histamine formation.  FDA investigators documented your failure to conduct histamine testing on lots of scombrotoxin forming fish exported to the USA.  In addition, our investigator documented your firm conducting sensory exams on (b)(4) fish per lot, rather than the (b)(4) fish per lot, as listed in your plan; and taking temperatures of ice and water in baskets holding scombrotoxic fish, rather than monitoring internal temperatures of the fish as listed in your plan.  

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 frozen headed and gutted scombrotoxin (histamine) forming fish does not list the critical control point of transit (receiving truck) to your facility for controlling the food safety hazard of histamine formation. 

Your firm is considered both a primary processor because you receive fish directly from the harvest vessels, and a secondary processor because you receive histamine forming fish on ice, transported by non-refrigerated trucks, from coastal ports as far as (b)(4) hours away, and it may be as long as (b)(4) hours from the time the fish are unloaded, sold, and delivered to your company.  Upon receipt by your facility and to ensure temperature control during transit, FDA recommends continuous monitoring of temperatures throughout the entire duration of the transit period.  This is to ensure that no temperature fluctuations occurred during the transit period, exposing the fish to temperatures above 40°F for extended time periods. You may accomplish this by requiring time/temperature data records or some similar method of monitoring on trucks; or monitoring for the presence of adequate ice or cooling media when receiving fish on ice or cooling media.

 Chapter 7 of the Fish and Fisheries Products Hazards and Controls Guidance provides additional information in determining which method is best suited to your process for control of the hazard of histamine formation.

3.  Because you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b).  However, your corrective action plan for frozen headed and gutted scombrotoxin (histamine) forming fish at the Reception critical control point is not appropriate. Your listed corrective action is to “subdivide lot and examine (b)(4) fish per sub-lot of histamine.”  FDA recommends rejection of the lot and discontinued use of the supplier until evidence is obtained that harvesting practices have changed.

We also note labeling deficiencies related to market names for seafood that your firm exports to the U.S.  Specifically, the acceptable market name for Chloroscombrus orqueta is bumper, and not leaf fish.  Katsuwonus pelamis should not be labeled as bonito, but as tuna; the only species that can be labeled as bonito are listed in 21 CFR 102.47. Lastly, the market name for Caranx caballus is jack and not blue runner.

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 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.  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 your deviations from the requirements of the Act or applicable regulations.  You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the Current Good Manufacturing Practice regulations (21 CFR Part 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 the Food and Drug Administration, Attention:  Priya Rathnam, 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 this letter, you may contact Ms. Rathnam by phone at (301) 436-2078 or via email at Priya.Rathnam@fda.hhs.gov



Jennifer Thomas
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition