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U.S. Department of Health and Human Services

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P.T. Intimas Surya 9/12/11


Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

College Park, MD

September 12, 2011


Warning Letter
I.D. # 199892 

Mr. Ivan Hans Jorgih, Director
Mr. Rian, Quality Assurance Manager
P.T.  Intimas Surya 
Jalan Ikan Tuna Raya #21
Pelabuhan Benoa
Denpasar, Bali, Bali

Dear Mr. Jorgih and Mr. Rian:

In response to a May 19, 2011, request by the United States Food and Drug Administration for a copy of your firm’s HACCP plan for tuna products, your firm responded via email on May 22, 2011 with a HACCP plan and supporting documents for “Frozen Steaks” that covered your frozen smoke-treated, vacuum-packaged tuna and marlin products. On May 26th your firm sent a follow-up email that contained an updated HACCP plan for “Frozen Steaks” which included one additional page dated May 26, 2011, addressing a labeling critical control point.  The remainder of the HACCP plan was the same as that provided in the May 22nd email.  Our evaluation of the HACCP plan you provided on May 26th and the supporting documentation revealed serious deviations from the requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 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 frozen smoke-treated, vacuum-packaged tuna and marlin covered under your HACCP plan for “Frozen Steaks” 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, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition (the Hazard Guide) through links in FDA’s home page at www.fda.gov.

We note the following seafood HACCP violations and other additional concerns:

A. Seafood HACCP violations

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 “Frozen Steaks” does not list the food safety hazard(s) of pathogen growth. 

Your firm’s “Product Description” provided as part of your HACCP documentation states that the intended use of the steaks includes “Ready to eat” as well as “cook before consumption.”  While your firm’s “Hazard Analysis Worksheet” identifies the hazard of a few pathogens, your firm presents the hazard as a sanitation-related hazard only to be addressed through GMPs and SSOPs. However, control of the food safety hazard of pathogen growth should be included in the HACCP plan, e.g. at the “Ice Brine Storage” and “Chilling” critical control points, in addition to the scombrotoxin (histamine) hazard, due to the intended raw consumption of at least some of the product.

2. 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 listed in your HACCP plan for “Frozen Steaks” are not appropriate at the following critical control points to control scombrotoxin (histamine):

a. At the “Receiving” critical control point, the internal temperature control component lists the corrective action as “reject any fish if exceed critical limit.”   This is in contrast to the histamine and decomposition control components of the receiving critical control point that properly instructs rejection of the entire “lot” when the critical limit is exceeded. The temperature component, like the other components, is intended to provide the processor with information about the condition of the entire “lot” that was sampled. Findings of elevated temperatures in individual fish in relation to the time of death should serve as an indicator of potentially inappropriate and unsafe harvest vessel handling practices of the entire lot.  It is not intended to simply (b)(4) measured for temperature, i.e. rejecting only those fish in which a high temperature was detected in the sample. 

b. At the “Chilling (Chiller Room)” critical control point, the listed corrective actions are inappropriate in association with the listed “Scombrotoxin Formation” hazard, in that your firm lists two separate corrective action strategies. In one, your firm will “Check temperature of all product in chiller” and conduct histamine testing on (b)(4) In the other strategy, your firm will test (b)(4) from chiller…for histamine” if the chiller (b)(4).  It is unclear whether both of these strategies will be implemented each time the chiller (b)(4) or if your firm intends to select only one strategy.  However, both strategies present deficiencies:

• Unless there are only a very few number of loins in the chiller at any given time, it will be difficult to measure the temperature of every loin in the chiller in a timely fashion that accurately reflects the condition of the fish following a critical limit excursion/deviation at the time it occurs (i.e., without re-chilling the potentially time and temperature abused fish while taking those temperatures).  In addition, it is also difficult to take sufficient measurements (both near surface and deep core temperatures) of each loin to ensure an appropriate assessment of the exposure has been made. Reliance only on the deep core temperatures of loins following a temperature control excursion/deviation will not provide reliable information about the exposure and condition of all of the edible portions of the loins since the deep core may take considerably longer to warm than portions nearer to the exposed surface of the loins.  Conversely, if there has been a temperature control deviation event, followed by some re-chilling, the surface portions of the loins may have re-chilled while deeper muscle may still be retaining some heat supporting microbial activity and potential scombrotoxin (histamine) formation.  

• When the fish are exposed to temperatures in (b)(4) your firm should be concerned that scombrotoxin (histamine) formation may have occurred sufficiently to render the fish unsafe. Conducting histamine testing on (b)(4) when your firm is aware that its preventative controls had been lost and the hazard could have been introduced is an inappropriate response or corrective action. If histamine testing is to be conducted as a corrective action in such a situation, FDA recommends that histamine testing of a minimum of 60 units should be conducted. If the product is still in a loin form, your firm should consider focusing a majority, but not all, of this testing on lower anterior loin portions within the chiller lot.  And if the chiller lot consists of loined fish from multiple suppliers with differing previous exposure histories, the processor should consider testing more than the minimum recommended 60 fish to ensure adequate representation of the fish.

• The (b)(4) criteria listed in the corrective action procedures may be found to be excessive after your firm properly incorporates and considers the hazard of pathogen growth. Depending on how (b)(4) that the temperatures of exposure get during the deviation, some pathogens could present a danger to consumers (b)(4). (Please refer to Table A-2 on page 421 of the 4th edition of FDA’s Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) for temperature exposure guidance related to pathogens.)

In addition to the above, FDA requests that your firm provide an explanation of the “time temperature of exposure” criteria that will form the basis of the corrective action evaluation of product associated with a critical limit deviation related to the “Clostridium botulinum toxin formation” hazard listed in the plan.  And the plan should reflect the action to be taken with the product if those criteria are exceeded.

B. Additional Concerns

1. Concerns with the listed controls at the “Receiving” critical control point:

a. Assessment of fish by harvest vessel versus comingled lots from collection vessels:

At the “Receiving” critical control point in your firm’s HACCP plan, your  firm uses the terms “Each lot every receiving” and “Every fish in every incoming lot” in the monitoring procedures frequency. It is unclear what your firm means by the term “lot”; however, your firm should be making assessments of “lots” in order to make individual harvest vessel determinations of the safety of the fish received (i.e., based on each individual harvest vessel). This is intended to provide the primary processor with assurance that each harvest vessel properly harvested, handled, and stored fish in a manner to prevent scombrotoxin (histamine) formation. 

Consequently, unless the fish delivered by the collection vessels have maintained the identity of the individual harvest vessels in association with segregated lots off-loaded and your firm’s reference to “lots” is to these segregated harvest vessel lots, assessments of fish from comingled harvest vessel “lots” as received from collection vessels complicates and reduces the level of assurances.  In such cases where the fish are commingled, FDA recommends increased levels of sampling and evaluations (i.e., when variability is expected in the lot). 

Moreover, it is not clear how your firm intends to implement the listed corrective action plan to “Identify source of raw material” and “discontinue of supplier until evidence is obtained that harvesting practice have changed” if your firm is unable to determine the individual harvest vessels. 

b. Internal temperatures upon off-loading fish from vessels or at processing facility:

Your firm’s HACCP plan lists a control component associated with the internal temperature of the fish “at time of receiving.”  However, your firm off-loads fish from the vessels at a pier and then loads the fish onto a box truck for a short transport to your processing facility across the street.  FDA’s recommended receiving control is intended to ensure the fish temperatures are adequate at the time they are off-loaded from the vessel as an indicator of vessel controls

c. Histamine sample location, sample preparation, and test method:

i. Your firm’s HACCP plan identifies the use of the (b)(4) test kit for monitoring the concentration of histamine in fish at the “Receiving” critical control point. A processor is obligated to verify that the method used for monitoring the critical limits is capable of reliably and accurately measuring the limits under the conditions within the firm’s own operations. Moreover, because your firm uses the kit for analyzing composite samples, you should ensure that the kit is applicable and reliable at the lowered critical limit level, i.e. 17 ppm. 

ii. With regard to sample collection and preparation for histamine, FDA recommends collecting a minimum of 250 grams from the lower anterior loin of each of the test fish, selected randomly and representatively collected from the lot. The entire sub-sample from each fish should be individually ground. When compositing, a minimum of 100 grams from each of the individually ground sub-samples should be combined and homogenized before collecting the test aliquot from the composite sub-sample.

d. Decomposition as a control for the hazard of scombrotoxin (histamine) formation:

In your HACCP plan, your firm distinguishes between a “Decomposition” hazard and a “Scombrotoxin Formation” hazard at the “Receiving” critical control point.  However, FDA’s recommended controls at receiving for primary processors that include sensory examinations for decomposition are intended to address the hazard of scombrotoxin (histamine) formation since sensory indicators of decomposition can serve as a warning to the primary processor that the fish were subjected to time-temperature abuse and may not be safe (i.e., due to the potential for scombrotoxin (histamine) formation during the unobserved abusive conditions on the vessel).

2. Concerns with listed controls at the “Ice Brine Storage” critical control point:

a. At the “Ice Brine Storage” critical control point, where raw gilled and gutted fish are off-loaded from transport trucks and placed into bins of “ice brine mixture” to hold the fish prior to processing, your firm lists two critical limits, i.e. “Product…held [in an] adequate ice brine mixture” and “Product temp. must be (b)(4). The “What” and “How” components of the listed monitoring procedures call for a “Visual check” for “adequate ice on fish” and to “Check random temperature internal of fish,” respective to the two critical limits. However, the monitoring frequency listed then calls for “check temp. ice brine” from the time of receipt of the fish and (b)(4). The listed controls are of concern for the following reasons:

• Monitoring “product” temperature and “ice brine” temperature are inconsistent within the listed procedures. The temperature of the ice brine where the fish are stored would provide an appropriate control, but the controls list visual checks for ice and not the use of a temperature monitoring device. Additionally, the procedures do not ensure that each bin in storage will be checked for ice or brine temperature, nor is there information on the number or percentage of bins to be monitored. 

• Measuring “product” temperatures as a control appears to be a concern because the control strategy does not list how many fish or how many bins will be monitored.  Additionally, if by the term “internal” temperatures of fish, your firm intends to take the deep core of large fish like tuna and marlin, the temperatures will not reflect the condition of all of the edible muscle.  In order to be a reliable measure, near surface temperatures of the fish, as well as deep core temperatures, should be taken.

b. The corrective action procedures listed at this critical control point appear to indicate only adding ice to the brine when found to be inadequately iced (either by visual or temperature determination which is inconsistent in the plan). When fish have been exposed to inadequate coolant, a processor should be concerned about the potential excessive scombrotoxin (histamine) formation.  Moreover, the listed corrective actions related to the product temperature control list the histamine testing of “Any individual fish test (b)(4). Unless every fish in storage is monitored for temperature (near surface and deep core) as part of the routine monitoring, or every fish in storage is measured for temperature as a result of a critical limit deviation, then it is not certain that the corrective action is going to take into account conditions of all fish within the lot or whether the action will only address those individual fish that were checked as part of the “random” monitoring.  The monitoring should be appropriate to address adequate control of all fish and that corrective actions, when warranted, will take into consideration the entire lot when controls have been lost or exceeded.

In addition, the monitoring frequency lists temperature measurements when fish are initially arriving and every four hours thereafter.  This frequency may suffice as long as exposure temperatures never exceed 70°F, but may not be sufficient from a monitoring and corrective action standpoint when the exposure temperatures exceed 70°F. 

3. Concerns with the listed controls at the “Chilling (Chiller Room)” critical control point for smoke treated fish:

a. At the “Chilling” critical control point, your firm lists critical limits to ensure the chiller room is maintained at both (b)(4) to address the  Clostridium botulinum toxin hazard; and (b)(4) to address the scombrotoxin (histamine) formation hazard. While both hazards may be listed at this one step, your firm should ensure that the most conservative temperatures are met, i.e., the (b)(4) to address the Clostridium botulinum toxin hazard. 

b. Your plan lists “Continuous” monitoring with “Visual check Digital thermometer” “per hour” in relation to the scombrotoxin (histamine) control.  Please confirm that your firm is using equipment capable of continuously monitoring and recording temperatures on a 24 hour a day/7 day a week basis, and that you are visually checking the record of the printout. 

Documenting manual observations of a thermometer every hour (including nights and other non-processing times as applicable) may serve as an adequate control; however, it does not constitute “continuous” monitoring even though the thermometer may reside in the cooler measuring temperature continuously.  Please provide a copy of the “Chiller Temperature Record” as listed in the plan.

In addition, the monitoring procedures associated with the “Clostridium botulinum toxin formation” hazard component of the “Chilling” critical control point refer to a “High temperature with 24 hour monitoring”, “Continuous”, “logger” temperature monitoring device from which “data [is] downloaded” and “Check[ed] once per day.”  Please explain whether the data logger is also equipped with a high temperature.  Please provide a copy of the “Logger data record”.

4. Concerns with the “Keep Frozen…” statement as applied to frozen vacuum-packaged, fresh fish:

a. Your firm includes a “Receiving of Labeling” CCP to control the Clostridium botulinum toxin hazard that can occur in the final, frozen, vacuum-packaged product. However, your firm should also include instructions to thaw under refrigeration and use immediately. In addition, your firm should clarify that the control is implemented at the finished product labeling step or describe how labeling controls are adequate to ensure that the proper statements are included at the time labels are received.

b. In addition, the undeclared allergen hazard associated with fish proteins, which was not identified in your firm’s hazard analysis or HACCP plan, could also be controlled at the product labeling processing step by ensuring that the species of fish is properly declared on each label (see Chapter 19 of the Hazards Guide).  And, while not a hazard, the final product labeling step is also an opportunity to ensure the actual “smoke” ingredient is declared in the ingredient list. 

5. Concern with excess chlorine concentration for food contact:

At the “Receiving,” “Ice Brine Storage,” “Cleaning” processing steps, your firm’s “Pre-Requisite Program,” dated 10/10/10, lists the washing and brushing of the surface of fish with (b)(4). FDA does not permit direct chlorine contact with fish in excess of 10 ppm. Chlorination using acidified sodium chlorite is permissible for contact up to 50 ppm when followed by a potable water rinse. 

You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation that would assist us in evaluating your corrections, such as a copy of any revised HACCP plans, at least five (5) days of production monitoring records to demonstrate that you have implemented the revised plan, any verification records, and any other useful information. If you cannot complete all corrections within thirty (30) days, you should explain the reason for your delay and state when you will correct any remaining violations.

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 [21 CFR Part 123] is Import Alert #16-120.  This alert can be found on FDA’s web site at: 

Please send your reply to the Food and Drug Administration, Attention: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing
and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A.  If you have any questions regarding this letter, you may contact Ms. Benjamin by phone at (240) 402-1424 or via email at Mildred.Benjamin@fda.hhs.gov 



Michael W. Roosevelt  
Acting Director
Office of Compliance
Center for Food Safety
  and Applied Nutrition