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  5. PT. SIG ASIA - 592584 - 10/28/2019
  1. Warning Letters

WARNING LETTER

PT. SIG ASIA MARCS-CMS 592584 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Seafood/Seafood Product
Recipient:
Recipient Name
Ms. Shaun Tan
Recipient Title
Chairwoman
PT. SIG ASIA

Jl. Lumba-Lumba Lingkungan IV, RT. 01, RW. 04
Kel. Girian Bawah, Kec. Girian
Bitung
Sulawesi Utara 95542
Indonesia

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

5001 Campus Drive
College Park, MD 20740
United States

Dear Ms. Tan:

In response to a request by a representative of the United States Food and Drug Administration (FDA) on July 12, 2019 for a copy of your firm’s HACCP plan for the scombrotoxin-forming  fish your firm imports into the Unites States, your firm provided a HACCP plan entitled “HACCP FROZEN TUNA” for your tuna products, which are intended to be consumed raw or cooked, shipped frozen , and may be vacuum packaged, as well as 5 complete sets of monitoring records associated with the HACCP plan.  Our review of the HACCP plan and records revealed that the plan demonstrates serious deviations from the requirements of the seafood Hazard Analysis Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123).

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 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 FDA’s 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.  The 4th Edition of the Hazards Guide can be found on our web site at:
https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/seafood/ucm2018426.htm

We found 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 entitled “HACCP FROZEN TUNA” dated April 14, 2019 does not list the food safety hazard of pathogen growth and toxin formation as a result of time and temperature abuse that is reasonably likely to occur in your raw ready-to-eat products. 

According to your HACCP plan, your firm (b)(4). Pathogen growth is reasonably likely to occur in fish and fishery products that are exposed to unrefrigerated temperatures (e.g. temperatures above 4.4° C (40° F) for unsafe periods of time.  Therefore, FDA recommends your HACCP plan include controls for pathogens in your ready-to-eat tuna products.

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 entitled “HACCP FROZEN TUNA” does not list a critical control point for unrefrigerated processing, or critical control points for all of the unrefrigerated processing steps, for controlling the food safety hazard of scombrotoxin (histamine) formation. Your HACCP plan should include control for unrefrigerated processing from when the first fish in a marked batch is removed from ice at the “(b)(4)” critical control point until the last finished product from the marked batch is placed in the freezer.

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 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 entitled “HACCP FROZEN TUNA” lists critical limits at the following critical control points that are not adequate to control scombrotoxin (histamine) formation and Clostridium botulinum toxin formation:

  • a) At the “(b)(4)” critical control point, to control scombrotoxin (histamine) formation, FDA recommends that, in addition to your critical limits for histamine testing and internal temperature, your HACCP plan list a critical limit for sensory analysis of a representative number of fish that shows decomposition in less than 2.5% of the fish in the sample.
  • b) At the “(b)(4)” critical control point, to control scombrotoxin (histamine) formation, FDA recommends the products are held at a cooler temperature of 40°F (4.4°C) or below; or the products are completely and continuously surrounded by ice throughout the storage time.
  • c) At the “(b)(4)” critical control point, to control Clostridium botulinum toxin formation, FDA recommends the products are held at a cooler temperature of 38°F (3.3°C) or below; or you ensure the products are completely and continuously surrounded by ice throughout the storage time. According to your description of the “(b)(4)” step, your firm places tuna products in a (b)(4) bag, fills with carbon monoxide gas, ties the bags closed, and stores refrigerated for up to (b)(4) days. 

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 corrective action plans for frozen tuna at the following critical control points are not appropriate.  Specifically,

  • a) At the “(b)(4)” critical control point, the listed corrective actions are not appropriate to control scombrotoxin (histamine) formation.  FDA recommends that affected lots be chilled and held until histamine analysis is performed on a minimum of 60 fish collected representatively throughout the lot, including any fish measured to have temperatures that exceeded the critical limit and any fish observed to have been exposed to inadequate cooling media (or the entire lot for lots smaller than 60 fish). Reject the lot if any fish are found with histamine greater than 50 ppm (17 ppm if lot is composited) and you discontinue use of the supplier or carrier until evidence is obtained that the identified transportation-handling practices have been improved.  Please note that is not appropriate to retest the fish in the lot to obtain compliance with the critical limit.
  • b) At the “(b)(4)” critical control point, the listed corrective action, “(b)(4)” is not adequate to control scombrotoxin (histamine) formation. When the critical limit is not met, FDA recommends that you chill and hold the product until it can be evaluated based on its total time and temperature exposure, including exposures during prior processing operations, destroy the product, or divert to a non-food use and ensure that the cause of the deviation is corrected.
  • c) At the “(b)(4)” critical control point, the listed correct actions, “(b)(4)” are not adequate to control Clostridium botulinum toxin formation. When the critical limits are not met, FDA recommends that you chill and hold the affected product until an evaluation of the total time and temperature exposure is performed, destroy the product, or divert to a non-food use and correct the cause of the deviation.
  • d) At the “(b)(4)” critical control point, the listed correct actions, “(b)(4)” and “(b)(4)” are not adequate to control scombrotoxin (histamine) formation. When the critical limits are not met, FDA recommends that 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. 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 (17 ppm if lot is composited), destroy the product, or divert the product to a non-food use and correct the cause of the deviation.
  • e) At the “(b)(4)” critical control point, the listed corrective action, “(b)(4) is not adequate by itself to control Clostridium botulinum toxin formation. FDA recommends that, in addition to (b)(4) you determine and correct the cause of improper labels.

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 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 Brandon Bridgman, 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 Mr. Bridgman via email at Brandon.Bridgman@fda.hhs.gov. Please reference # 592584 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

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