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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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New Life Corporation 6/7/12


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

Public Health Service
Food and Drug Administration
 College Park, MD


June 7, 2012
Mr. Gilberto Cedeno, President
New Life Corporation
Apartado Postal 042600452
David, Chiriqui, Panama
                                                Re:  # 302398
Dear Mr. Cedeno:
This letter is in response to the information and documentation your firm provided on March 23, 2012 which was provided to the Agency in response to our letter to your firm dated February 17, 2012. In your March 23, 2012, response, you submitted a HACCP plan dated 22/03/12 and five (5) days of receiving records. Our evaluation of this documentation identified serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). 
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 species of fish appear to be 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 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.  
We note 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 21 123.6(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 Mahi Mahi Fresco provided with your March 23rd response does not list the significant hazard of undeclared allergens.
FDA recommends that in order to control the hazard of undeclared allergens, firms include a critical control point to visually check each lot of labels to ensure that the allergenic substance (i.e., the fish species) is accurately declared on the labels. 
2.      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 revised HACCP plan dated 22/03/2012 for Mahi Mahi Fresco provided with your March 23rd response fails to list a critical limit for decomposition detected during the sensory evaluation at the Receiving critical control point. FDA recommends sensory examination of a representative sample of scombrotoxin-forming fish 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.
3.      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 for Mahi Mahi Fresco provided with your March 23rd response  lists a monitoring procedure/frequency at the:
a.       Process critical control point that is not adequate to control histamine. Specifically, your firm’s plan states, “the length time the fish are exposed to unrefrigerated conditions above 40°F (4.4°C) b(4) an ambient temperature during processing operations.” However, for “how” of the monitoring, your plan states, “use dial or digital thermometer for internal temperature.” b(4) FDA recommends when fish are held unrefrigerated for extended time periods that firms measure the ambient air temperature of the processing room, with a frequency of at least every 2 hours.
b.      Storage critical control point that is not adequate. Your firm’s plan lists monitoring for the adequacy of ice or cooling media and cooler temperature. However, for “how” of the monitoring, your plan states, “use dial or digital thermometer for internal temperature” b(4) and “… visual observation of adequacy of ice or cooling media…” b(4) FDA recommends that firms use equipment capable of continuously monitoring and recording the cooler temperatures.
4.      Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan at:
a.       Process critical control point is not adequate.  FDA recommends that firms chill and hold the affected product until histamine analysis is performed on a minimum of 60 fish representatively collected throughout the affected lot. If histamine analysis is unacceptable, FDA recommends that the lot is destroyed or diverted to a non-food use.
b.      Storage critical control point is not adequate. Your corrective actions listed in the plan do not correct the problem that caused the critical limit deviation.
The 4th Edition of the Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. Your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records to demonstrate implementation of the plan or plans, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations.  Submission of the information in English will assist in our review.
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 website at: http://www.fda.gov/ora/fiars/ora_import_ia16120.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 and Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may send any information related to this case and/or any questions you may have regarding this letter to Standra Purnell via email at: standra.purnell@fda.hhs.gov.
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
   and Applied Nutrition