WARNING LETTER
Pavlos Trifonidis S.A
MARCS-CMS 585386 —
July 30, 2019
Delivery Method:
Via Express Delivery
Recipient:
Recipient Name
Mr. Petros Trifonidis
Recipient Title
Chief Executive Officer
Pavlos Trifonidis S.A
Industrial Area of Kavala
Chrysoupoli
64200
Kavala
Greece
Issuing Office:
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park
,
MD
20740-3835
United States
JUL 30, 2019
WARNING LETTER
Reference #585386
Dear Mr. Trifonidis:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Pavlos Trifonidis S.A., located at Industrial Area of Kava la, Chrysoupoli, Kava la on March 14 to 15, 2019. 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, lnspectional Observations, listing the observations made at your firm. We acknowledge receipt of your responses sent via email on April 5 and June 10, 2019. Your responses included revised HACCP plans along with corresponding HACCP documents. However, our evaluation of your response revealed it was not adequate, 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 tuna "Lakerda (Thunnus alalunga)" packed in oil and canned salted anchovies 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 41h 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.
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,
a. Your firm's revised HACCP plan provided with your June 10th response entitled "
(b)(4)
" lists a critical limit of "
(b)(4)
" at the "
(b)(4)
" critical control point. Specifically, a critical limit for core temperature of the fish, is not appropriate to control scombrotoxin (histamine) formation. FDA recommends a critical limit that ensures the product is held at a continuous cooler temperature of 40°F (4.4°C) or below, or ensure the product is completely and continuously surrounded by ice throughout the storage time.
b. Your firm's revised HACCP plan provided with your June 10th response entitled "
(b)(4)
" lists critical limits of "
(b)(4)
" and "
(b)(4)
" at the "
(b)(4)
" critical control point. These critical limits are not adequate by themselves to control scombrotoxin (histamine) formation when receiving fresh fish from the harvest vessel. In addition to taking internal temperature of incoming scombroid species fish, FDA recommends conducting a sensory examination of a representative number of incoming fish for decomposition; and controls that include either obtaining harvest vessel records that demonstrate the fish were properly maintained while onboard the vessel; or conducting histamine testing at receipt from harvest vessels with a limit of less than 50 ppm histamine as the critical limit for the histamine analysis. For more information on scombrotoxin (histamine) formation controls at receiving, see Chapter 7 of the Hazards Guide.
Lastly, when processors rely on the adequacy of ice during transit from the harvest vessel to the plant, FDA recommends a critical limit that lists fish are to be completely surrounded by ice during transit and at the time of delivery.
c. Your firm's revised HACCP plan provided with your June 10th response for "
(b)(4)
" lists a critical limit of "
(b)(4)
," at the "
(b)(4)
" critical control point. This is not adequate to control scombrotoxin (histamine) formation. In order for histamine forming fish to be safely processed at ambient temperatures above 40°F (4.4°C) for up to 8 hours, FDA recommends that processors ensure that no portion of that time is at temperatures above 70°F. Your critical limit should reflect this temperature limitation.
d. Your firm's revised HACCP plan provided with your June 10th response for "Lakerda (Thunnus alalonga) IN OIL" lists critical limits of "
(b)(4)
," "
(b)(4)
," "
(b)(4)
," at the "
(b)(4)
" critical control point. These critical limits are not adequate to control your identified hazards of scombrotoxin (histamine) formation, Staphylococcus aureus growth and toxin formation, and Clostridium botulinum growth and toxin formation. Specifically:
• Your HACCP plan does not list a critical limit for Brine Temperature to control scombrotoxin (histamine) formation and Staphylococcus aureus growth and toxin formation. FDA recommends a brine temperature of 40°F (4.4 "C) or below. In addition, your firm should monitor the temperature of the brine in the warmest location within each brining bin continuously, using a continuous temperature recording device (e.g., a recording thermometer).
• Your critical limit for Brine Salinity to control scombrotoxin (histamine) formation, Staphylococcus aureus growth and toxin formation, and Clostridium botulinum growth and toxin formation is "
(b)(4)
" (i.e., "
(b)(4)
") which should instead be listed as the more appropriate critical limit of "
>
25° Baume" (i.e. "greater than or equal to").
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 revised HACCP plan provided with your June 10th response for "Lakerda (Thunnus alalonga) IN OIL" does not list the critical control point of storage in the cool room for controlling the food safety hazards of scombrotoxin (histamine) formation and Clostridium botulinum growth and toxin formation.
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,
a. Your firm's HACCP plan for "Salted Anchovies" lists a monitoring procedure at the "
(b)(4)
" critical control point that is not adequate to control scombrotoxin (histamine) formation. FDA recommends that firms monitor the internal temperature of a representative number of fish from throughout the shipment, at delivery, for every scombrotoxin-forming fish lot received.
b. Your firm's HACCP plan for "Salted Anchovies" lists a monitoring procedure at the "
(b)(4)
" critical control point that is not adequate to control scombrotoxin (histamine) formation, Staphylococcus aureus growth and toxin formation, and Clostridium botulinum growth and toxin formation. FDA recommends that firm's monitor the salinity during curing as often as necessary to maintain control.
c. Your firm's HACCP plan for "Lakerda (Thunnus alalonga) IN OIL" (tuna) lists a monitoring frequency for processing room temperature at the "
(b)(4)
" critical control point that is not adequate to control scombrotoxin (histamine) formation. FDA recommends firms monitor the temperature at least every 2 hours, rather than once per batch.
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 listed corrective actions for "Lakerda (Thunnus ala longs) IN OIL" at the "
(b)(4)
" critical control point and for "Salted Anchovies" at the "
(b)(4)
," "
(b)(4)
," "
(b)(4)
," and "
(b)(4)
" critical control points are not appropriate because they do not ensure that adulterated product does not enter commerce. When processors include corrective actions in their HACCP plan, the corrective actions must ensure that no adulterated products will enter commerce as a result of a deviation in addition to correcting the cause of the deviation.
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. 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., 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 believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
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.
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 Current Good Manufacturing Practice regulation (21 CFR 117 Subpart 8). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Additional Comments:
• Your firm's HACCP plan for "Salted Anchovies" lists verification procedures at the "
(b)(4)
" critical control point that are not adequate to Clostridium botulinum growth and toxin formation in the finished product. FDA recommends that firms conduct finished product sampling and analysis to determine water phase salt or water activity level, as appropriate, at least once every 3 months (except where such testing is performed as part of monitoring).
• Your firm's HACCP plan for "Lakerda (Thunnus alalonga) IN OIL" lists a verification procedure at the "
(b)(4)
" critical control point that is not adequate to control Clostridium botulinum growth and toxin formation in the finished product. FDA recommends that firms conduct finished product sampling and analysis to determine water phase salt or water activity level, as appropriate, at least once every 3 months (except where such testing is performed as part of monitoring). FDA recommends that refrigerated, reduced oxygen-packaged fishery products have a water phase salt level of at least 5% or a water activity of below 0.97.
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 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. 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 re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). 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.
You should direct your written reply to Marco Esteves, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Marco Esteves via email at marco.esteves@FDA.hhs.gov. Please reference CMS #585386 on any submissions and on the subject line of any emails to us.
Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Content current as of:
09/03/2019