Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
JUL 1, 2015
VIA EXPRESS DELIVERY
Ignatios Petropoulos, CEO
P.O. Box 312, Kimmeria
Xanthi, Greece 67100
Reference # 460487
Dear Mr. Petropoulos:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility Kalloni S.A. located in Kimmeria, Xanthi, Greece on January 26-27, 2015. During that inspection, we found that you had 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, listing the observations made at your firm.
We acknowledge receipt of your response sent via email on February 17, 2015. Your response included a written description of the corrective actions your firm has taken and a revised HACCP plan for your salted mackerel, anchovies and sardines. We have evaluated the documentation and found that you have continuing serious deviations of the seafood HACCP regulation, as further explained 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 salted mackerel, anchovies and sardines 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 Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm.
Your significant deviations are as follows:
1. 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 revised HACCP plan for “Salted Fish (Anchovies, Sardines, Chub Mackerel) dated February 12, 2015, does not list critical control points to control the food safety hazards of scombrotoxin (histamine) formation and pathogen growth and toxin formation. Your fish products are scombroid species and are ready to eat, consequently they pose risks for scombrotoxin (histamine) formation and pathogen growth as a result of time and temperature abuse. Your firm needs to include critical control points to control time and temperature abuse. Specifically, your plan does not include:
a. Refrigerated Storage of your incoming raw materials, following receipt when the fish are held prior to processing.
b. Storing of fish in saturated brine and ice between the “Deheading/gutting” and “Salting” steps. During the inspection, we observed that you store the fish in ice, as an intermediate step between the deheading/gutting steps and the salting step for an extended time period. Consequently, your firm needs to ensure that the fish are held under adequate ice or cooling media during this storage step, to prevent time and temperature abuse conducive to scombrotoxin (histamine) formation and pathogen growth.
2. You must have a HACCP plan that, at a minimum, lists the critical limits, 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 February12, 2015, lists critical limits at the following critical control points that are not adequate, or fails to list critical limits to control the associated hazards. Specifically:
a. At the “Receiving/Harvest Control/Transit Control” critical control point, your revised HACCP plan fails to list adequate critical limits to control scombrotoxin (histamine) formation that is reasonably likely to occur onboard the harvest vessel. Although your plan lists critical limits for (b)(4), your plan does include the third recommended component which includes either histamine testing or obtaining harvest vessel records to ensure that the fish were properly handled while onboard the vessels. Discussions during the inspection revealed that your firm will not able to obtain harvest vessel records, consequently, we recommend that your firm adopt an adequate histamine testing protocol. Your plan should ensure that you set an adequate critical limit for histamine levels and include monitoring procedures that ensure testing is conducted on a representative number of fish in each lot, in addition to your listed critical limit (b)(4). FDA currently requires that histamine content not exceed 50 parts per million (ppm).
b. At the “Salting” critical control point, your revised plan lists a critical limit, “(b)(4),” that is not adequate to control pathogen growth/toxin formation and histamine. FDA recommends that you also list the minimum and maximum values for the salting process such as the salt to fish ratio, or actual values for the weight of salt and the weight of fish at this step.
In addition, your plan lists (b)(4) the Deheading/gutting and Salting critical control points (b)(4) critical control point (i.e., a (b)(4) at these two critical control points). The “Intensive pressing” critical control point then lists (b)(4). These critical control points (b)(4). Consequently, it appears that the cumulative exposure time at controlled temperatures of 21°C or below is (b)(4). However, FDA recommends in order to control pathogens and histamine, that firms limit the total exposure time to 8 hours when temperatures are controlled at or below 21°C during processing operations, until the fish reach a safe Aw level (i.e., reach an Aw of 0.85 or below). As an alternative to listing three (3) separate critical control points, your firm may choose to combine these into one critical control point, particularly because these (b)(4). The critical limits would include time, temperature and either the final Aw (e.g., demonstrating a final Aw of 0.85) or the parameters established by a scientific study demonstrating that the products reach the appropriate Aw (e.g., fish/salt ratio, brine strength, start/finish weight of the salted pressed fish) within 8 hours.
3. You must have a HACCP plan, that at a minimum, lists monitoring procedures and their frequency, to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP plan dated February 12, 2015, lists monitoring procedures and frequencies at the following critical control points that are not adequate to control the associated hazards. Specifically, at the “Fish Receiving/Harvest Control/Transit Control” critical control point, your firm’s plan:
a. Lists at the internal temperature step, “(b)(4),” which is not adequate because it does not include how many fish will be monitored. For example, FDA recommends measuring the internal temperature of a representative number of the largest fish in each lot at the time of off-loading from the harvest vessel by the processor, concentrating on any fish that show signs of having been mishandled (e.g., inadequately iced). FDA recommends that this monitoring activity include a minimum of 12 fish, unless there are fewer than 12 fish in the lot, in which case internal temperature of all of the fish should be measured; and visual determination of the date and time of off-loading.
b. Lists at the decomposition step, “(b)(4),” which is not adequate because it does not include a sampling strategy for when you receive less than 12 boxes. For example, FDA recommends your firm examine at least 118 fish, collected representatively throughout each lot (or the entire lot, for lots smaller than 118 fish).
c. Lists at the (b)(4), that you will “(b)(4),” which is not adequate because it does not ensure that the fish were continuously maintained at proper temperatures for the duration of the transit period. For example, FDA recommends that you continuously monitor the chamber temperature within the truck throughout transportation using a continuous temperature-recording device.
4. Pre-determined corrective action plans, when included in a HACCP plan must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective actions at the following critical control points are not appropriate:
a. At the “Fish Receiving/Harvest Control/Transit Control” critical control point, your revised HACCP plan indicates (b)(4),” however, it does not define how the product will be sampled and tested. If you intend to (b)(4) as a corrective action when internal temperature and decomposition critical limits are not met, FDA recommends that your firm chill and hold the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the lot (or the entire lot for lots smaller than 60 fish), including any fish measured to have temperatures that exceeded the critical limit. We recommend that your firm reject the lot if any fish are found with histamine greater than or equal to 50 ppm. In addition, when the (b)(4) critical limit has not been met, you should also perform a sensory examination of all fish in the lot to ensure that no decomposed fish proceed, and that any individual fish that is found to be decomposed (persistent and readily perceptible) should be destroyed or diverted to a non-food use.
b. At the “Deheading/gutting” and “Intensive Pressing” critical control points, your firm’s revised HACCP plan indicates (b)(4),” which is not adequate for the following reasons:
i. The (b)(4) for scombrotoxin (histamine) as listed in the plan does not define how the product will be sampled and tested. The use of histamine analysis as a corrective action is recommended when the cumulative time and temperature critical limits have not been met. When using histamine analysis as part of a corrective action plan, FDA recommends holding the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the lot, and destroying the lot or diverting it to a non-food use if any fish are found with histamine greater than or equal to 50 ppm.
ii. The (b)(4) is not recommended as part of a corrective action plan because conducting (b)(4) will not ensure that adulterated product does not enter commerce. We recommend instead that your corrective actions include an assessment of the time and temperature exposures above your listed critical limits to ensure adulterated product does not enter commerce. In addition, your corrective action plan needs to include how you will evaluate or adjust your equipment or process to correct the cause of the deviations.
c. In addition, FDA recommends that you chill and hold the product until it can be evaluated based on its water activity level, adjust your process, or reprocess the product (if reprocessing does not jeopardize the safety of the product) when your critical limits at the “Salting” or “Intensive Pressing” critical control points are not met.
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, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products)to demonstrate implementation of the plan, 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 seafood HACCP regulation. 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.
In addition to the above violations, we also have the following comments regarding your labels.
- Your product label fails to declare Trans Fat as required by 21 CFR 101.9(c)(2)(ii).
- Your product label declares “Vegetable Oil,” which is multi-component ingredient, however, it fails to list each individual fat and/or oil ingredient as required by 21 CFR 101.4(b)(14).
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 re-inspection-related costs. A re-inspection is 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
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.
Please send your reply to Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Purnell via email at email@example.com.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition