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WARNING LETTER

Tuna Paradise Co. Ltd. MARCS-CMS 537186 —


Recipient:
Recipient Name
Mr. Kalai Selvan
Tuna Paradise Co. Ltd.

49/7 Moo 7, T.Khokkloy, A.Takuathung

Takuathung, Phang Nga
82140
Thailand

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740 

WARNING LETTER

SEP 28, 2017

VIA EXPRESS DELIVERY

Mr. Kalai Selvan, Chief Executive Officer
Tuna Paradise Co. Ltd.
49/7 Moo 7, T.Khokkloy, A.Takuathung
Takuathung, Phang Nga, 82140 Thailand

Reference #537186

Dear Mr. Selvan:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Tuna Paradise Co., Ltd., 49, 7 T.Khokkloy, A.Takuathung, Takua Thung, Phangnga, Thailand on August 7 & 8, 2017. The inspection revealed serious violations of the seafood HACCP regulation [Title 21, Code of Federal Regulations, Part 123 (21 CFR123)]. That inspection resulted in FDA's issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. To date, we have not received a response to the observations made during the FDA inspection of your facility.

In accordance with 21 CFR 123, failure of a seafood facility to operate in accordance with the requirements of 21 CFR 123, renders the tuna 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 products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and 21 CFR 123 through links in FDA's home page at www.fda.gov.

We note the following significant 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 CFR 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 histamine forming fish does not list the food safety hazard of Clostridium botulinum toxin formation for frozen, raw vacuum packaged tuna steaks. For example, FDA recommends that firms ensure each individual vacuum package includes instructions to be held frozen and to be thawed under refrigeration immediately before use (e.g., "Important, keep frozen until used, thaw under refrigeration immediately before use").
 

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 Part 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 forming fish does not list the critical control point of unrefrigerated processing, including thawing of your frozen tuna, for controlling the food safety hazard of scombrotoxin (histamine) formation.

3. 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 Part 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 forming fish lists critical limits at the "(b)(4)" critical control point that are not adequate, by themselves, to control scombrotoxin (histamine) formation that is reasonably likely to occur onboard the harvest vessel and during transit.

a. As a primary processor receiving the fish directly from the harvest vessel, to control scombrotoxin (histamine) formation that is reasonably likely to occur on board the harvest vessel, FDA recommends, in addition to histamine testing and sensory evaluation, establishing a critical limit(s) for the internal temperature of the fish at the time of offloading from the harvest vessel for the fresh fish you receive. For example, FDA recommends:

• For fish held iced or refrigerated (not frozen) onboard the vessel 24 or more hours after death:

o The internal temperature should be 40°F (4.4°C) or below;
OR

• For fish held iced or refrigerated (not frozen) onboard the vessel from 15 to less than 24 hours after death:

o The internal temperature should be 50°F (l0°C) or below;
OR

• For fish held iced or refrigerated (not frozen) onboard the vessel from 12 to less than 15 hours after death:

o The internal temperature should be 60°F (15.6°C) or below;
OR

• For fish held iced or refrigerated (not frozen) onboard the vess el less than 12 hours after death:

o The internal temperature should be sufficiently below water and air temperatures to indicate that appropriate chilling methods were implemented on board the harvest vessel. Chilling of the fish should begin on the harvest vessel regardless of the time from death until offloading from the vessel by the processor, unless the environmental conditions (e.g. air and water temperatures) are below 40°F (4.4°C) from the time of death until off-loading from the vessel by the processor;
OR

• For fish held iced or refrigerated (not frozen) on board the vessel:

o Elapsed time from death and internal temperatures at the time of offloading from the vessel by the processor should be consistent with cooling curves that will prevent development of an unsafe level of histamine in the specific species, as established through a scientific study

b. To control scombrotoxin {histamine) formation that is reasonably likely to occur during transit to your facility from the wharf or from a previous processor, FDA recommends, for example:

• For fish delivered refrigerated (not frozen):
OR

o All lots received are accompanied by transportation records that show that the fish were held at or below an ambient or internal temperature of 40°F (4.4°C) throughout transit. Note that allowance for routine refrigeration defrost cycles may be necessary;

• For fish delivered under ice:
o Fish are completely surrounded by ice at the time of delivery;
OR

• For fish delivered under ice on an open-bed truck:
OR

o Fish are stored completely surrounded by ice;
AND
o The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;

• For fish delivered under chemical cooling media such as gel packs:
OR

o There is an adequate quantity of cooling media that remain frozen to have maintained product at an internal temperature of 40°F (4.4°C) or below throughout transit;
AND

o The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;• For fish delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less (optional control strategy):
o Time of transit does not exceed 4 hours;
AND
o Internal temperature of the fish at the time of delivery does not exceed 40°F {4.4°C).

4. You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP elan for histamine forming fish lists a monitoring procedure and frequency at the "(b)(4)" critical control point that are not adequate to control scombrotoxin (histamine) formation. Specifically, your firm lists that you will monitor the internal temperature of fresh fish at the time of delivery at this critical control point, however your firm does not include the monitoring procedures. For example, FDA recommends monitoring the internal temperature of the fish at the time of delivery using a temperature-indicating device (e.g., a thermometer) to determine internal product temperatures in a representative number of fish from throughout the shipment. Additionally, we recommend measuring a minimum of 12 fish, unless there are fewer than 12 fish in a lot, in which case measure all of the fish. Lots that show a high level of temperature variability or lots of very small fish may require a larger sample size.

5. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21CFR123.7(b). However, your corrective action plans for histamine forming fish at the following critical control points to control scombrotoxin (histamine) formation are not appropriate. Specifically,

a. At the "(b)(4)" critical control point, your corrective action plans for temperature of the fish and decomposition indicate that you may "(b)(4)" the incoming lots when the critical limits are not met without further clarification as to the disposition of the lot. However, FDA recommends, for example, that:

• When the internal temperature critical limit has not been met AND if histamine did not exceed 50 ppm in the initial testing, firm's:
AND

o Chill and hold the affected lot (i.e., fish of common origin) 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). Reject the lot if any fish are found with histamine greater than or equal to 50 ppm. The fish collected for analysis may be composited for analysis if the action point 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

o Reject the lot;
 

• When the sensory examination critical limit has not been met AND if histamine did not exceed 50 ppm in the initial testing:
o Chill and hold the affected lot (i.e ., fish of common origin) 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). Reject the lot if any fish are found with histamine greater than or equal to 50 ppm. The fish collected for analysis may be composited for analysis if the action point 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;
AND

o If any fish in the lot are to proceed into commerce for food use, perform a sensory examination of all fish in the lot to ensure that no decomposed fish proceed;
AND

o Any individual fish found to be decomposed (persistent and readily perceptible) should be destroyed or diverted to a non-food use;
OR
o Reject the lot.

b. At the "(b)(4)" critical control point, your corrective action plan for deviations from your temperature critical limit indicates that you can process the affected product when the product passes a sensory test . However, FDA recommends, for example, that firms:

• Chill and hold the product until it can be evaluated based on its total time and temperature exposure, including exposures during prior processing operations.
OR
• Chill and hold the affected product until histamine analysis is performed on a minimum of 60 fish collected from throughout each affected lot. 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 point 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.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, including your revised HACCP plan and 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. Responding in English will help to assist us in our review of your documentation.

If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your frozen, raw, vacuum packaged tuna 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 (21 CFR 123) is Import Alert 16-120, Detention without Physical Examination of Fish and Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP. This alert can be found on FDA's web site at: https://www.accessdata.fda.gov/cms_ia/importalert_25.html

This letter may not list all the deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the Seafood HACCP regulations (21 CFR 123), and the current Good Manufacturing Practices 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 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 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.

Please send your reply to the Food and Drug Administration, Attention : Rosemary Sexton, Compliance Officer, Office of Compliance, Division of Enforcement, Food Assessment and Adulteration Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Rosemary Sexton via email at rosemary.sexton@fda.hhs.gov. Please reference case# 525906 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition 

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