WARNING LETTER
Thai Union Group PLC
MARCS-CMS 630100 —
April 20, 2022
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Wachira Katueang-Ngan
Recipient Title
Quality Manager
Thai Union Group PLC
72/1 Moo 7 Sethakit 1 Road
Tambon Tarsrai
Amphoe
,
Mueang
Samut Sakhon
74000
Thailand
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
April 20, 2022
WARNING LETTER
Reference # 630100
Dear Ms. Wachira Katueang-Ngan:
The United States Food and Drug Administration (FDA) conducted a Foreign Remote Regulatory Assessment (FRRA) of your seafood processing facility, Thai Union Group PLC, located at 72/1 Moo 7 Sethakit 1 Road, Tambon Tarsrai, Amphoe Mueang Samutsakhon, Samutsakhon, 74000, Thailand on January 18-20 & 25, 2022. An on-site inspection was not possible due to travel restrictions during the COVID-19 pandemic. During the remote assessment, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR Part 123). At the conclusion of the assessment, the FDA investigator discussed items of concern. We acknowledge your email responses dated, February 1, 2022, and March 1, 2022, to the discussion items identified during the FRRA.
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 frozen, pre-cooked tuna loin 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.
Your significant deviations are as follows:
1. You must have a HACCP plan that at 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 “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 frozen precooked tuna loins lists a critical limit of “
(b)(4)
” at the Precooking critical control point (CCP 11) that is not adequate to control scombrotoxin (histamine) formation. FDA recommends you establish critical limits for the minimum or maximum values for the critical factors established by a scientific study, which may include length of the cook cycle, speed of the belt for a continuous cooker, temperature of the steam or water used for cooking, initial temperature of the product, product form (loin, whole fish, etc.), and any other critical factors that affect the rate of heating the product. Alternatively, you may establish a value for the end product internal product temperature (EPIPT), established by a scientific study.
Your Temperature Distribution Testing Report and Heat Penetration Testing Report provided during the inspection do not support the listed critical limit of “
(b)(4)
.”
a. The Temperature Distribution Testing Report documents the result of temperature distribution within “
(b)(4)
” located at “
(b)(4)
” but the Heat Penetration Testing Report documents results for “
(b)(4)
” and “
(b)(4)
” located at “
(b)(4)
.” In order to scientifically validate the cooking process, the scientific studies used to establish critical limits should be conducted for and applied to each individual cook tunnel.
b. Although the “Test Procedure” section of the Heat Penetration Testing Report states that the thermocouples (TC) should be placed in the geometric center of the product at the thickest point near the backbone,” the photos on page 3 of the report show temperature sensors placed in tuna loins and not in whole, headed and gutted or any tunas with backbones. It does not appear that the heat penetration study is representative of the whole tuna processed under the “
(b)(4)
” HACCP plan, which lists the “
(b)(4)
” step as occurring after the “
(b)(4)
” step.
Additionally, your “
(b)(4)
” is identified as the scheduled process of precooked tuna (For USA) and includes Skipjack, Bigeye, Yellowfin, and Albacore tuna. The document lists multiple sizes for each species and a corresponding “
(b)(4)
.” It is unclear how this document relates to the listed critical limit of “
(b)(4)
” or how it relates to the Heat Penetration Testing Report. Since multiple sized batches are processed, the critical limit should include ensuring each fish of each batch weighs less than a specific maximum size to ensure that all fish are processed to achieve a uniform heat penetration with a minimum internal temperature of 60°C.
2. You must have a HACCP Plan that at 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 frozen precooked tuna loins lists a monitoring frequency at the following critical control points that is not adequate. Specifically:
a. The unrefrigerated processing critical control points for steps “3-19” (CCP 10) lists a monitoring frequency of “-Every bin of raw material -Every trolley of precooked fish” that is not adequate to control scombrotoxin (histamine) formation because it does not include a unit of time between measurements. FDA recommends monitoring cumulative exposure time at a frequency of every 2 hours.
b. The unrefrigerated processing critical control point for steps “19-33, 44” (CCP 12) lists a monitoring frequency of “-Every precooked fish trolley” that is not adequate to control scombrotoxin (histamine) formation because it does not include a unit of time between measurements. FDA recommends monitoring cumulative exposure time at a frequency of every 2 hours.
c. The unrefrigerated processing critical control point for steps “22-33,40” (CCP13) lists a monitoring frequency of “-Every precooked fish trolley” that is not adequate to control
Staphylococcus aureus
growth and toxin formation because it does not include a unit of time between measurements. FDA recommends monitoring cumulative exposure time at a frequency of every 2 hours.
3. You must implement the monitoring procedures and frequency that you have listed in your HACCP Plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure of “
(b)(4)
” at the unrefrigerated processing critical control point for steps “3-19” (CCP 10) to control scombrotoxin (histamine) formation. FDA recommends continuous ambient temperature monitoring (air and water surrounding fish) from the time a lot of fish exits cold storage until the time a lot of fish enters the
(b)(4)
step.
According to your submitted Corrective Action report, [the] “production department has designated PD Staffs to check temperature of water in the fish tank by thermometer at the end of
(b)(4)
step. PD staffs has recorded its temperature for monitoring the temperature control at
(b)(4)
step.” Monitoring the water temperature at the end of the
(b)(4)
step is not consistent with your listed monitoring procedure of “
(b)(4)
” and does not ensure that the fish were not exposed to temperatures above 4.4°C (40°F) during tempering (or thawing).
Your “Attach No.3 – Validation of temperature from the each step.xlsx,” document showed that the total time fish are exposed to temperatures above 4.4°C (40°F) between the start of step 3 until step 19 (raw material transportation to precooking) take over 19 hours (1166 minutes). We acknowledge that the water temperature during tempering and thawing varies. It appears you are using thermocouples to monitor the water temperature during tempering and thawing. If the thermocouples are connected to continuous temperature monitoring device that produces a history of the water temperature during these steps, this would allow for continuous monitoring and documentation of the actual amount of time fish are exposed to water temperatures above 4.4°C (40°F) (see “Attach No.1 – Temperature control at
(b)(4)
step.pdf”).
4. Since you chose to include corrective actions in your HACCP Plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan listed at the following critical control points are not appropriate. Specifically:
a. The metal detecting critical control point (CCP 2) lists a corrective actions of “If any product was rejected by metal detector, action shall be taken one as following: 1) the fish shall be rejected, or 2) the fish shall be separated for sorting out the metal fragments and after removed the metal fragment, re-pass the fish through metal detector again before releasing” is not adequate because it does not address the cause of the critical limit deviation. In order to regain control over the operation, FDA also recommends you attempt to locate and correct the source of the fragments found in the product by the metal detector.
b. The unrefrigerated processing critical control point for steps 3-19 (CCP 10) does not ensure unsafe product doesn’t reach the consumer or correct the cause of the critical limit deviation. To ensure unsafe product does not reach the consumer, in addition to your listed corrective action of “perform histamine analysis on the fish lot by analyzing minimum of 60 fish, including all fish that show evidence of decomposition,” FDA recommends you also add instructions to destroy the lot or divert it to a non-food use if any fish is found with histamine greater than or equal to 50ppm. To correct the cause of the critical limit deviation, FDA recommends you modify the process as needed to reduce exposure time. Note that the listed corrective action to “reject the lot which is all raw material bins that take longer than control time and greater than control temperature at each step” is not appropriate because it represents an action taken for a critical limit deviation for processing temperatures, but the CCP does not contain a temperature critical limit.
c. The unrefrigerated processing critical control point for steps 19-33,40 (CCP 12) lists a corrective action of “If cumulative time from after precooking until start of freezing exceeds 12 hours, then specifically identify the involved trolley of tuna, segregate and immediately expedite processing, then conduct histamine analysis at cleaning for 60 tuna randomly selected from the identified racks based on composites from 3 tuna (20 composites) If any composite exceeds 10ppm histamine, then reject all identified rack.- Depending on evidence, each of the 60 individual fish can be analyzed whereby all identified tuna are rejected if any one fish exceeds 30ppm. – Determine and correct cause for the excessive exposure time”. This corrective action is not adequate to ensure unsafe product does not reach the consumer or correct the cause of the critical limit deviation.
To ensure unsafe product does not reach the consumer, FDA recommends you:
• chill and hold the affected product until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the affected lot and 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. The fish collected for analysis may be composited if the action plan is reduced accordingly. For example, a sample of 60 fish may be composited into 20 units of 3 fish each, provided the action point is reduced from 50 ppm to 17 ppm for each unit;
OR
• Destroy the product;
OR
• Divert the product to a non-food use.
AND: to regain control over the operation and correct the cause of the critical limit deviation, FDA recommends you:
• Add ice to the product;
OR
• Return the affected product to the cooler;
AND
• Modify the process as needed to reduce the time and temperature exposure.
d. The Unrefrigerated Processing critical control point for steps 22-33,40 (CCP 13) lists a corrective action of “If the accumulated time is more than the critical limits reject the products” that is not adequate to ensure unsafe product does not reach the consumer or correct the cause of the critical limit deviation.
To ensure unsafe product does not reach the consumer, FDA recommends you:
• Chill and hold the affected product until an evaluation of total time and temperature exposures is performed;
OR
• Destroy the product;
OR
• Divert the product to a non-food use.
AND: to regain control over the operation and correct the cause of the critical limit deviation, FDA recommends you:
• Determine cause of deviation
AND
• Modify the process as needed to reduce time and temperature exposure.
We acknowledge your revised HACCP plan dated “22/02/22”. This HACCP plan outlines a process where tuna is loined after the
(b)(4)
step. The technical review conducted was based upon the updated flowchart provided with the updated HACCP Plan. However, your description of the traditional process for vacuum-packed frozen tuna loins outlines processing steps that conflict with the steps outlined in the updated HACCP plan dated 22/02/22. Clarification is needed to determine which is utilized during production, the actual process outlined in the updated flowchart and updated HACCP plan dated “22/02/22”. If the actual process, the updated flowchart, and updated HACCP plan do not align with actual processing taking place, hazards might not be identified and/or adequately controlled during processing.
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 Part 117, Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should direct your written reply to Rosemary Sexton, 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 Rosemary Sexton via email at Rosemary.Sexton@fda.hhs.gov. Please reference CMS #630100 on any submissions and on the subject line of any emails to us.
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
10/18/2022
Regulated Product(s)
Food & Beverages