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WARNING LETTER

PT. Primo Indo Ikan MARCS-CMS 581917 —

Delivery Method:
Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Lucas J. Papiemiak
Recipient Title
Director
PT. Primo Indo Ikan

888 Moaniala Street
Honolulu, HI 96821-2548
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

5001 Campus Drive
College Park, MD 20740-3835
United States

WARNING LETTER

May 30, 2019

VIA EXPRESS DELIVERY

Mr. Lucas J. Papiemiak, Director
PT. Primo lndo Ikan
888 Moaniala Street
Honolulu, HI 96821-2548

Reference # 581917

Dear Mr. Lucas J. Papiemiak:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, PT. Primo Indo Ikan, located at JI. Ikan Tuna I No. 1, Denpasar, Bali, 80223, Indonesia on January 21 and 22, 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 response to the FDA-483 received via email on February 4, 2019, which included a revised HACCP plan, entitled "Frozen Tuna Fish" dated January 23, 2019 for frozen, vacuum packed tuna and additional HACCP documents, including records titled, "Product Description", "Hazard Analysis", "GMP" and "SSOP". Review of the documentation revealed that your response is 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 frozen, vacuum packed 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 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.

Your significant deviations are as follows:

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 HACCP plan entitled "Frozen Tuna Fish," provided with your response and dated January 23, 2019, does not list the food safety hazards of pathogen growth and toxin formation including Clostridium botulinum (C. botulinum).

a. Your firm processes tuna products that, according to your "(b)(4)", are likely to be consumed raw and where pathogen growth will present a safety hazard. 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, prior to the final freezing step.

b. In addition, your firm (b)(4) the raw tuna products with carbon monoxide (CO) during processing and vacuum packages the finished product, both which pose a hazard for C. botulinum growth and toxin formation.

i.  When processors hold fish and fishery products under oxygen limiting (anaerobic) conditions which are conducive to C. botulinum growth and toxin formation, such as treating tuna with CO during processing, FDA recommends that the processor include this treatment step as critical control point in their HACCP plan. Therefore, C. botulinum needs to be identified as a hazard at the "Incubation" (CO treatment) step where the flesh color is preserved, and the fish is held under anaerobic conditions. In addition, FDA recommends that holding temperatures not exceed 3.3°C (38°F) during the CO treatment process.

ii.  For raw fish products that are vacuum packaged, HACCP plans need to assure that the end-product is appropriately labeled with handling instructions (e.g., "Important, keep frozen until used, thaw under refrigeration immediately before use") to prevent C. botulinum growth and toxin formation during storage and distribution of fish and fishery products. Therefore, the labels of your frozen vacuum packaged products need to include handling instructions and your HACCP plan needs to include a monitoring step to ensure the statement is on each lot of labels.

2. You must have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 (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 "Frozen Tuna Fish," dated January 23, 2019, does not list one of more critical control points to control the food safety hazard of histamine formation.

Histamine formation can occur in the absence of refrigeration or time/temperature controls during unrefrigerated processing steps. Your plan fails to identify multiple processing steps as critical control points (e.g., washing, cutting/loin, cutting kama, cutting belly non CO, gassing and degassing, skinning/trimming, weighing, stuffing, saku/ steak/ cubes/ CC/ SM/ NS/ BL) to prevent unsafe cumulative time/temperature exposures and refrigerated holding steps (e.g., chilling room) where temperatures need to be maintained at or below 4.4°C(41°F) to prevent histamine formation. These steps may also be likely critical controls points for pathogen growth.

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 HACCP plan entitled "(b)(4)" dated January 23, 2019, lists critical limits of "(b)(4)", and histamine levels "(b)(4)" at the "(b)(4)" critical control point that are not adequate by themselves to control histamine formation.

In addition to your listed critical limits, FDA recommends including critical limits to assure safe handling conditions aboard the harvest vessels and to assure safe transportation conditions from offloading to your processing facility:

a. With regard to ensuring the safe handling after capture, FDA recommends assuring that less than 2.5% of the fish examined in a representative sample show evidence of decomposition (persistent and readily perceptible odors of decomposition). For example, no more than 2 fish in a sample of 118 fish may show signs of decomposition. Decomposition is an indication of potentially unsafe handling conditions due to time and temperature abuse.

Per your document entitled, "GMP", attached to your HACCP plan, at the (b)(4) you conduct organoleptic examination of the tuna which are graded for odor, texture, and freshness using a score sheet for every "(b)(4)". FDA recommends including organoleptic examination as an additional critical limit at the "Receiving" critical control point in your HACCP plan.

b. Your plan needs to include a critical limit at the "(b)(4)" critical control point to ensure that safe temperatures were maintained during transit from the harvest vessel to the processing plant, to prevent histamine formation. For example, FDA recommends that for fish delivered under ice, there be a critical limit ensuring that the fish are completely surrounded by ice at the time of delivery.

4. 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, your firm 's HACCP plan entitled "Frozen Tuna Fish," dated January 23, 2019, lists a monitoring frequency at the "(b)(4)" critical control point that is not adequate to control histamine formation. To monitor "(b)(4)" your plan calls for a frequency of "(b)(4)". This is not sufficient as described. For example, your plan lists (b)(4) FDA recommends that a minimum of 12 fish per lot be monitored for internal temperature and that if less than 12 fish are received, that the entire vessel lot is monitored. In addition, the plan needs to specify that the internal temperatures are monitored at offloading.

5. 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 plan for "Frozen Tuna Fish" at the "(b)(4)" critical control point to control the identified hazards are not appropriate. Specifically, the plan lists corrective actions that do not include ensuring the cause of the deviation is corrected.

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, such as 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 believe you have complied with FDA regulations, 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. This alert can be found on FDA's web site at: http://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 processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP and the current Good Manufacturing Practice Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (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.

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 Food and Drug Administration, Attention: Aleta Flores, Compliance Officer, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Aleta Flores via email at aleta.flores@fda.hhs.gov. Please reference CMS# 581917 on any submissions and within 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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