VIA United Parcel Service
July 27, 2016
Mr. Shawn Tanoue, President
Tropic Fish Hawaii, LLC
2312 Kamehameha Hwy, Unit E-5
Honolulu, HI 96819
Dear Mr. Tanoue:
We inspected your seafood processing facility, located at 2312 Kamehameha Hwy, Unit E-5, Honolulu, HI 96819 between the following dates: May 17 and 20, 2016. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor offish 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 fresh, refrigerated histamine-forming fish products, including Ahi tuna, mahi mahi, and skipjack tuna, 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 & Controls Guidance through links in FDA's home page at www.fda.gov
We acknowledge your firm's response, received on June 13, 2016, to the FDA 483 Inspectional Observations we issued to you at the close of our recent inspection. Your response does not adequately address all the deviations observed. The deviations listed in this letter are based on observations we made during the inspection and our review of your firm's HACCP plan for fresh, refrigerated histamine-forming fish products, (i.e. tuna), intended for raw consumption, entitled "(b)(4)", for product description: "(b)(4).
Your significant violations are as follows:
1. 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 for fresh, refrigerated histamine-forming fish, including tuna, does not list the critical control point of refrigerated storage for controlling the food safety hazard of scombrotoxin (histamine) formation.
Your response received on June 13, 2016 included that you do not list refrigerated storage as a critical control point (CCP) because you have continuous monitoring of the room. However, your continuous temperature monitoring was not working at the time of our inspection and we acknowledge in your response that the system has since been fixed and placed into operation. In your Hazards Analysis Worksheet, which was collected during our inspection, you justified the lack of your "(b)(4)" as a CCP because you are "(b)(4)" and preventive measures of monitoring storage temperature and adding ice may control histamine formation. Your response is not adequate and your hazards analysis is not correct. Your firm's HACCP Manager informed our investigator during our inspection that fresh fish can be stored up to (b)(4) prior to processing and distribution. On May 18, 2016, our investigator observed the temperature of your (b)(4) used for refrigerated product storage to be at 44 °F and the internal temperature of two Ahi tuna in this room at 42°F. The significant hazard of scombrotoxin (histamine) formation must be controlled at this CCP in the event a critical limit has been exceeded to determine possible time and temperature abuse. In your response, you noted your included computerized monitoring temperature log of your refrigerated storage shows spikes in temperatures (above 40°F). The FDA recommends the following critical limits to be set at cold storage control:
For refrigerated (not frozen) storage or processing ofraw material, in-process product, or finished product:
• The product is held at a cooler temperature of 40°F (4.4°C) or below. Note that allowance for routine refrigeration defrost cycles may be necessary. On the other hand, minor variations in cooler temperature measurements can be avoided by submerging the sensor for the temperature-recording device (e.g. temperature-recorder) in a liquid that mimics the characteristics ofthe product. Also note that critical limits during refrigerated storage that specify a cumulative time and temperature of exposure to temperatures above 40°F are not ordinarily suitable because of the difficulty in tracking the specific products and the specific cumulative temperature exposures that those products experience. The cumulative exposure for each product would then need to be determined prior to shipping. If you chose this approach, the critical limit for cumulative exposure to temperatures above 40°F should include the time during transit, refrigerated storage, and refrigerated and unrefrigerated processing;
• If you choose to store products under ice: the product is completely and continuously surrounded by ice throughout the storage time.
Please refer to Chapter 7 (Scombrotoxin (Histamine) Formation) of the Fish and Fisheries Products Hazards & Controls Guidance: Fourth Edition for additional information related to the hazards and appropriate control strategies for storage of your products.
2. You must 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(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,
a. your firm's HACCP plan for fresh, refrigerated histamine-forming fish (i.e. tuna) does not list the food safety hazard of pathogenic bacteria growth for the fish which are intended for raw consumption .
Your response received on June 13, 2016 stated that you do not list pathogenic bacteria growth and toxin formation as a hazard because you have implemented a variety of programs to avoid this hazard and have never had a problem with the control of this hazard. In your firm's Hazards Analysis Worksheet, which was collected during our inspection, you did not consider pathogenic bacteria as a potential hazard in any processing step. Only at the "(b)(4)" step, you identified "bacterial pathogens", but indicated that this is not a significant food safety hazard and justified your decision that you are using potable water. Your response is not adequate and your hazards analysis is incorrect. FDA has identified pathogenic bacteria growth and toxin formation as a food safety hazard in finfish (i.e. tuna) intended for raw consumption and control of this significant hazard must be included in your HACCP plan in the event of time and temperature abuse.
b. your firm's HACCP plan for fresh, refrigerated histamine-forming fish (i.e. tuna) does not list the food safety hazard of parasites for skipjack tuna. Parasites is a species-related food safety hazard in skipjack tuna intended for raw consumption and must be addressed in your firm's HACCP plan.
In your firm's Hazards Analysis Worksheet, which was collected during our inspection, you considered parasites as a potential hazard at receiving and justified that it is not a significant hazard because the product is to be fully cooked prior to consumption. However, this is incorrect because the intended use as indicated on the HACCP Plan states that your fresh, refrigerated histamine-forming fish products are intended to be consumed raw.
Please refer to Chapter 5 (Parasites) and 12 (Pathogenic Bacteria Growth and Toxin Formation as a Result of Time and Temperature Abuse) of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition for additional information related to determining appropriate critical limits, monitoring procedures and critical control points to control the hazards of parasites and pathogenic bacteria.
3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CPR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure of measuring the internal temperature of a representative number of fish at the "Receiving" critical control point to control scombrotoxin (histamine) formation as listed in your HACCP plan for fresh, refrigerated histamine-forming fish (i.e. tuna). Specifically, your firm was observed measuring the surface temperature of the fish via an infrared thermometer upon receipt at your firm.
Your response received on June 13, 2016 stated that you have now resumed taking the internal temperature of the fish with a probe thermometer. We will verify the adequacy of your corrective action during our next scheduled inspection.
4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CPR 123.11(b). However, your firm did not monitor prevention of cross-contamination from insanitary objects; condition and cleanliness of food contact surfaces; and control of employee health conditions with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CPR Part 110 as evidenced by:
a. Prevention of cross-contamination from insanitary objects:
On May 17, 2016, our investigator observed unprocessed Ahi tuna, which is intended for raw consumption, being stored on the concrete floor in the (b)(4). Our investigator then observed the employee dragging the Ahi tuna across the floor onto a pallet after management instructed the employee to place the fish onto pallets.
Your response received on June 13, 2016 stated that the employee received a written warning and was counseled, extra pallets have been staged in the (b)(4) to add more storage space, and plastic platform trucks have been ordered to help move products. However, your response is not completely adequate because you have not addressed the steps you have taken to ensure prevention of other employees from engaging in the same practice.
b. Condition and cleanliness of food contact surfaces:
On May 18, 2016, our investigator observed unprocessed mahi mahi being stored in a heavily damaged white plastic bin with its interior gouged and stained brown.
Your response received on June 13, 2016 stated that you have discarded the bins that were stained and cracked. However, your response is not completely adequate because you have not addressed how you will ensure the plastic bins or other food contact surfaces are monitored with sufficient frequency to ensure the condition and cleanliness of them are acceptable for use.
c. Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces:
Employee health conditions are monitored only (b)(4) according to your firm's (b)(4). The monitoring of employee health conditions are not documented on your (b)(4).
Your response received on June 30, 2016 did not address the lack of monitoring of employee health conditions on a more frequent basis than (b)(4).
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).
a. your corrective action plan for fresh, refrigerated, histamine-forming fish (i.e. tuna) as listed in your HACCP plan at the "Receiving" CCP to control the hazard of scombrotoxin (histamine) formation is to dispose decomposed fish at a local animal feed company or other non-food use; reject the lot; destroy product; or add ice and monitor the internal fish temperature for product found to be inadequately refrigerated. This corrective action plan is not adequate because it does not include how you will correct the cause of the deviation.
b. your correction action plan for fresh, refrigerated, histamine-forming fish (i.e. tuna) as listed in your HACCP plan at the "Processing" CCP to control the hazard of scombrotoxin (histamine) formation is to add ice and/or move some or all the product to the cooler to regain control over the operation after a specification (critical) limit deviation; or destroy the product or divert the product to animal feed or other non-food use This corrective action plan is not adequate because does not include how you will correct the cause of the deviation.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating. This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Our review also found the following:
• In your HACCP plan for fresh, refrigerated histamine-forming fish (e.g. tuna), the written descriptions under each critical control point and the subsequent chart formats outlining those critical control points are not consistent. During our inspection, your HACCP Manager informed our investigator that your firm (b)(4). However, we suggest that the written description and chart format of your HACCP plan be consistent to avoid confusion. We observed several discrepancies between the two. For example, at the "Processing" CCP, the "Specification Limits" described in the written description is "(b)(4)", while the chart for this CCP lists "(b)(4)". As written, the description of the "Processing" critical control point specifically applies to Skipjack only while the subsequent chart specifically applies to Tuna only; however, according to your HACCP Manager, the HACCP plan applies to all scombrotoxin-forming fish, including "(b)(4)" as listed on the first page of the HACCP plan.
• Furthermore, we recommend that your firm use the appropriate terminology of "Critical Limit" rather than "Specification Limit" in your HACCP plan to avoid confusion. The term "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, the term "Specification Limit" is not defined by FDA and it may not be explicitly clear on what this limit identifies in your plan.
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. Are-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 mean all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the inspection and assessing and collecting the inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic 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.
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. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to:
Food and Drug Administration
Attention: Lawton W. Lum, Director, Compliance Branch
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
Refer to the Unique Identification Number (b)(4) when replying.
If you have questions regarding any issues in this letter, please contact Lydia S. Chan, Compliance Officer, at (510) 337-6776.
Kathleen M. Lewis, J.D.
Charles Umamoto, President
CMU & Associates, Inc.
55 Holomua St.
Hilo, HI 96720