DEPARTMENT OF HEALTH & HUMAN SERVICES
February 17, 2012
Mr. Gilberto Cedeno
New Life Corporation
Apartado Postal 042600452
Dear Mr. Cedeno:
We inspected your seafood processing facility, New Life Corporation, located at Antigua Tiburonera Pedregal, David, Chiriqui, Panama on July 18-19, 2011. Upon further review of our investigator's inspection report and findings during the inspection, we determined 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.
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 firm’s scombrotoxin (histamine) forming species of fish appear to be adulterated, in that the products have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. At the conclusion of the inspection the FDA investigator issued a FDA-483, Inspectional Observations, listing the deviations found at your firm.
We acknowledge receipt of your response, to the FDA-483, dated August 30, 2011 that included blank monitoring records, photographs, as well as descriptions of corrections made at your facility and completed monitoring records. However our review revealed that the response was not adequate, as further described in this letter.
You may find the Act and the Seafood HACCP regulation through links in FDA’s home page at www.fda.gov.
We note the following serious deviations from the requirements of the Seafood HACCP regulation:
- 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 collected during the inspection and intended for your scombrotoxin (histamine) forming species of fish does not include a strategy to ensure that the fish were properly handled on board the harvest vessels. As a primary processor receiving the fish directly from the harvest vessels, FDA recommends either obtaining harvest vessel records or conducting adequate histamine testing, as a critical limit at the Reception critical control point. Specifically the plan only lists sensory examination and internal temperature. For additional information specifically related to receipt of fish as a primary processor, please refer to pages 125 to 136 of the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance.
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 HACCP plan response lists a monitoring procedures/frequency at the:
“Sensory” step of the Reception critical control point that is not adequate to control histamine. Specifically, your firm’s plan does not list as a monitoring procedure that includes the number of fish to be analyzed and does not indicate that a representative sample of scombrotoxin-forming fish will be analyzed. (e.g. examine 118 fish per lot on a representative number of fish in the lot; or all fish in the lot if less than 118 fish).
“Internal temperature” step for the Reception critical control point does include the number of fish to be sampled. For example FDA recommends measuring a minimum of 12 fish, unless there are fewer than 12 fish in the lot, in which case all of the fish should be measured.
Process critical control point that is not adequate. Specifically, your firm’s plan states that the “…internal temperature” will be monitored, however FDA recommends monitoring ambient temperatures (i.e. air or water) when controlling histamine.
- Because you chose to include a corrective actions 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 HACCP plan at the “Fresh Fish Storage with ice” and “Process” critical control points are not adequate.
FDA recommends your corrective actions for a product involved in a critical limit deviation 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 chill and hold 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 destroy the product; or divert the product to a non-food use; and
- take corrective actions to regain control over the operation after a critical limit deviation and address the root cause.
For additional information regarding FDA’s recommended controls for the hazard associated with scombrotoxin (histamine) formation discussed above, please refer to Chapter 7 of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition, which can be found on FDA’s website at:
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 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.
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 the Seafood HACCP regulation. 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, 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 Standra Purnell via email at firstname.lastname@example.org.
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition