Inspections, Compliance, Enforcement, and Criminal Investigations
NALMA, S.A. 8/5/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20742
August 5, 2013
VIA EXPRESS DELIVERY
Via El Puerto-Aguadulce
Reference No. # 408047
Dear Mr. Matamoros:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility, Nalma S.A.,locatedat Via El Puerto-Aguadulce, Aguadulce, Panamaon January 31, 2013 and February 1, 2013. 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 an FDA-483, Inspectional Observations. We acknowledge receipt of your responses sent via email on February 15, 2013 and March 27, 2013. Your responses included various documents, including a description of corrections to the observations of concern noted on the FDA-483, and photo evidence of corrections. However, our evaluation of the documentation associated with the inspection revealed significant violations, as further described in this letter.
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 histamine-producing fish products 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 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
The Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Your significant deviations are as follows:
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 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 for histamine-producing fish lists critical control limits that are not adequate to control the hazard of histamine formation.
Your firm’s HACCP plan lists a critical limit for harvest vessel record at the receiving critical control point of “(b)(4)” that is not adequate to control histamine formation. FDA recommends that your critical limit for harvest vessel records also specify parameters for the amount of time before the fish are to be placed in ice; or in refrigerated seawater, ice slurry, or brine of 40 °F (4.4 °C) or less; based on the air and water temperatures to which the fish are exposed and based on exposure time to unchilled conditions.
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 histamine-producing fish does not list the critical control point of receiving the fish during transit from the wharf to your processing facilityto control the food safety hazard of histamineformation.
Your HACCP/GMP/SSOP manual states that the time the harvested fish are in transit from the time of offloading to your firm can range (b)(4). Proper temperature control of your histamine-producing fish is necessary during transit to your facility to prevent histamine production. For fish delivered under ice, FDA recommends that the fish are completely surrounded by ice at the time of delivery. For fish delivered under ice on an open-bed truck, FDA recommends that the fish are stored completely surrounded by ice and the internal temperature of the fish at time of delivery is 40 °F (4.4 °C) or below.
We note that youhave modified your receiving record to incorporate monitoring ice surrounding every fish and monitoring the internal temperature of every fish. These steps should be included as part of your monitoring procedures.
3. Predetermined corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). However, your corrective action plans for histamine-producing fish at the receiving and storage critical control points are not appropriate in that they do not ensure that potentially adulterated fish do not enter into commerce and that the causes of the critical limit deviations have been corrected.
With regard to the “(b)(4)” critical control point:
- In the absence of harvest vessel records or when one of the harvester-related critical limits has not been met, or when the internal temperature critical limit at receiving has not been met, FDA recommends that you either reject the lot or chill and hold the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the lot, including any fish measured to have temperatures that exceeded the critical limit (or the entire lot for lots smaller than 60 fish). If you choose to perform testing, FDA recommends that you reject the lot if any fish are found with histamine greater than or equal to 50 ppm.
- When the sensory examination critical limit has not been met, FDA recommends that you either reject the lot or chill and hold the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected from 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). If you choose to perform testing, FDA recommends that you reject the lot if any fish is found with histamine greater than or equal to 50 ppm. FDA further recommends that you perform a sensory examination of all fish in the lot to ensure that no decomposed fish proceed and that any individual fish found to be decomposed (persistent and readily perceptible) are destroyed or diverted to a non-food use.
- FDA recommends that you discontinue use of the supplier until you obtain information that harvesting and onboard practices and controls have been improved.
With regard to the “(b)(4)” critical control point:
- Although your corrective action of adding ice may prevent a further critical limit deviation, it does not address the root cause of the deviation.
- When your critical limit of “(b)(4)” is not met, your corrective actions associated with holding affected products to assess time and temperature exposures and destroying product that was exposed to temperatures (b)(4) can not be implemented because your firm is monitoring the presence of ice (b)(4). Consequently, your firm will not have the time and temperature parameters listed in your corrective action plan on which to make an evaluation.
FDA recommends that in the absence of time and temperature controls, you either destroy the lot; divert the lot to non-food use; or chill and hold the affected product until histamine analysis is performed on a minimum of 60 fish collected from throughout each affected lot. If you choose to test the lot, FDA recommends that you destroy the lot or divert it to a non-food use if any fish is found with histamine greater than or equal to 50 ppm.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, 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 (i.e., records for the production of 5 production date codes of the products) 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 cannot complete all corrections within 15 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. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html
We also have the following comments:
- The lot numbers on each of the completed Harvest Vessel Records submitted are identical for the different launch times on that record. Since your firm is associating the same lot number with different launch times, when a violation of a critical limit occurs, corrective actions must be taken on all lots with the same lot number.
- The Harvest Vessel monitoring records should document the method of capture; the estimated earliest time of death (for long lines this is likely the time the lines are initially cast); the time the last fish on the line is placed in ice, or in refrigerated seawater, ice slurry, or brine of 40 °F (4.4 °C) or less; the method of cooling and the temperature of the cooling medium; where applicable, the critical factors of the cooling process; the date and time of launch; and the air and water temperatures to which the fish are exposed.
- Your firm’s HACCP plan lists a critical limit at the receiving critical control point of “(b)(4)” that is not adequate to control histamine formation. FDA recommends a critical limit for decomposition of less than 2.5% of the fish in the sample, rather than no more than 2.5%. This means that there should be no more than two decomposed fish in a sample of 118 fish.
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 all applicable regulations, including 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.
Additionally, Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the U.S. Food and Drug Administration, Attention: Stuart A. Feldman, Consumer Safety 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 Mr. Feldman via email at email@example.com.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition