Inspections, Compliance, Enforcement, and Criminal Investigations
Diamond Head Seafood Wholesale, Inc. 8/8/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700
VIA UNITED PARCEL SERVICE
Our Reference: FEI No. 3001584338
August 8, 2012
Michael P. Irish, CEO
Diamond Head Seafood Wholesale, Inc.
966 Robello Lane
Honolulu, Hawaii 96817-4545
Dear Mr. Irish:
We inspected your seafood processing facility, Diamond Head Seafood Wholesale, Inc., located at 966 Robello Lane, Honolulu, Hawaii, on June 5, 7, 8, 11, and 13, 2012. 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 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 histamine forming fish including chilled mahi mahi, escolar, marlin, and refrigerated, raw, ready-to-eat 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 receipt of your president’s, Gary Ishimoto, June 26, 2012 letter and attachments in response to the FDA 483 List of Observations. The response to the current inspection does not adequately address all the deviations observed. The deviations listed in this letter are based on the inspection and our review of your response letter.
Your significant violations 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 firm’s HACCP plan for “Fresh Fish: dressed, loined, steaked (histamine forming fish species including tuna spp., mahi mahi, marlin, wahoo, skip jack, etc)” did not list the food safety hazard of pathogen growth and toxin formation as a result of time/temperature abuse of fish intended for raw consumption, and the food safety hazard of allergens.
We acknowledge that your firm did not consider pathogen growth and toxin formation in your Hazard Analysis Worksheet as a potential hazard likely to occur and justified your decision by stating that it is controlled by your (b)(4). However, FDA has identified pathogen growth and toxin formation as a food safety hazard and must be included in your HACCP plan. Likewise, FDA has identified finfish as a major allergen; as a food safety hazard, it must also be included in your HACCP plan.
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 for “Fresh Fish: dressed, loined, steaked (histamine forming fish species including tuna spp., mahi mahi, marlin, wahoo, skip jack, etc)” does not list the critical control points of:
- Processing at the Cutting Room and Poke Room, to control the food safety hazard of histamine formation and pathogen growth and toxin formation as a result of time/temperature abuse in refrigerated, raw, ready-to-eat tuna. On June 5, 2012, according to your Operations Manager/QC Manager and also based on FDA observation, depending on the grade of the fish and customer demand, in-process and finished raw, ready-to-eat tuna loins remain in your firm’s refrigerated Cutting Room for up to (b)(4) before they are packaged and distributed. The FDA noted that your data logger records for the Cutting Room show that the temperature exceeded 40°F for approximately 40 hours continuously between April 30, 2012 and May 2, 2012, reaching a high temperature of 50°F at 6:24 am on May 2, 2012. The temperature ranged from 41.9°F to 48.2°F for approximately 11 hours, continuously, beginning at 6:24 am on May 23, 2012. FDA noted that your data logger records for the Poke Room show that the temperature exceeded 40°F for more than 96 hours continuously between May 1, 2012 and May 5, 2012, reaching a high temperature of 48.2°F at 10:25 am on May 1, 2012. The temperature ranged from 41°F to 47.3°F for approximately 14 hours, continuously, beginning at 6:25 am on May 17, 2012. The temperature ranged from 41.0°F to 61.7°F for more than 39 hours, continuously, beginning at 4:25 am on June 4, 2012.
In the absence of controls, cumulative time and temperature abuse conditions could occur during processing of the product and the processing step could contribute significantly to that cumulative abuse.
To establish the appropriate critical limits, monitoring procedures, corrective actions, verification, and record-keeping system, please refer to the 4th Edition of the HACCP Guide.
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 for “Fresh Fish: dressed, loined, steaked (histamine forming fish species including tuna spp., mahi mahi, marlin, wahoo, skip jack, etc)” list a critical limit (b)(4) at the Cold Storage critical control point. Storing fresh fish under this condition is not adequate to control histamine formation and pathogen growth and toxin formation. FDA recommends that the product is held at a cooler temperature of 40°F or below. Critical limits during the refrigerated storage that specify a cumulative time and temperature of exposure are not ordinarily suitable to control the hazard because of the difficulty in tracking the specific product and the specific cumulative temperature exposures that the product experiences.
4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point (CCP), to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for “Fresh Fish: dressed, loined, steaked (histamine forming fish species including tuna spp., mahi mahi, marlin, wahoo, skip jack, etc)” lists a monitoring procedure (b)(4) of the (b)(4) on the delivery vehicle, at the Receiving critical control point that is not adequate to control histamine formation and pathogen growth and toxin formation. For fish delivered under ice, FDA recommends making visual observations of the adequacy of ice from throughout the shipment at delivery; or for fish delivered under chemical cooling media such as gel packs for your imported fish or fish from the outer islands, FDA recommends making visual observation of the adequacy and frozen state of the cooling media in a representative number of containers from throughout the shipment.
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 “Fish is held and evaluated” for “Fresh Fish: dressed, loined, steaked (histamine forming fish species including tuna spp., mahi mahi, marlin, wahoo, skip jack, etc)” at the Receiving and Cold Storage critical control points to control histamine formation is not appropriate. Your corrective action does not ensure that adulterated product will not reach the consumer nor does it ensure that the root cause of the deviation is corrected.
At the Receiving critical control point, FDA recommends:
- Chill and hold the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the lot, including any with temperatures that exceeded a 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 is found with histamine greater than or equal to 50 ppm.
- Reject the lot.
- Discontinue use of the supplier or carrier until evidence is obtained that the identified transportation-handling practices have been improved.
At the Cold Storage critical control point, FDA recommends:
- Chill and hold the product until it can be evaluated based on its total time and temperature exposure, including exposures during prior processing operations.
- 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.
- Destroy the product;
- Divert the product to a non-food use
- To prevent further deviation, add ice to the product or move some or all of the product in the malfunctioning cooler to another cooler;
- To address the root cause, make repairs or adjustments to the malfunctioning cooler or make adjustment to the ice application operations.
6. You must monitor sanitation conditions and practices with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
(a) Condition and cleanliness of food contact surfaces – FDA observed that the cutting boards used to process raw, ready-to-eat tuna were deeply gouged and stained with debris. In addition, your firm’s large white plastic bins used to store fresh gilled and gutted mahi mahi in the storage room were stained with debris.
(b) Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garment, and from raw product to cooked product – FDA observed that your employees use hoses to spray water on the floor in the processing area, storage room, and receiving area within close proximity to fresh gilled and gutted, in process, and finished, ready-to-eat tuna. Water splashed from the floor onto fresh gilled & gutted and in process tuna. In addition, we observed your employees walking directly on pallets at the time of receiving fresh gilled and gutted tuna. These pallets are deeply gouged and stained and are used to store fresh gilled and gutted and in-process tuna. FDA also observed a hose nozzle handle was stored on the rim of an open trash can in the processing area. The nozzle handle was in direct contact with fish debris and rubbish. Employees used the hose and then resumed cutting raw, ready-to-eat tuna without washing their hands or changing gloves. At the weighing/packaging/labeling station located in the processing area, we observed an employee touching the computer mouse that was caked with grime and other debris, and then handled raw, ready-to-eat tuna without washing his hands or changing gloves.
(c) Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants – FDA observed that fresh gilled and gutted mahi mahi and barracuda were stored in the storage room directly underneath the air conditioning unit. Condensate from the air conditioning unit was seen dripping directly onto the mahi mahi. In addition, pallets containing fresh gilled and gutted tuna were stored in the storage room directly underneath the detergent and sanitizer station.
We acknowledge Mr. Ishimoto’s response and corrective action to the above observations associated with sanitation. We will verify the effectiveness and permanence of the corrections at the next inspection.
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 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations. 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.
You should respond in writing within fifteen (15) working days of 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 copies of the revised HACCP plans, 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.
On June 7, 2012, in conjunction with the inspection, we collected 31 environmental swab samples for microbial analysis from food contact and non-food contact surfaces in your firm’s processing and storage areas. These environmental swabs were identified with sub numbers in sample INV689423. Our laboratory found the presence of Listeria species in 6 environmental swabs. These are:
Environmental swab #5 found positive for Listeria monocytogenes. Swab sub-sample was collected from the inside surface of the large white plastic bin containing whole mahi mahi in the Chill Storage Room.
Environmental swab #21 found positive for Listeria monotyctogenes. Swab sub-sample was collected from the surface of the white portion of right side door in the Processing Room that leads to the Storage Room. The door sample was collected from a location where employees touch it to open.
Environmental swab #22 found positive for Listeria monocytogenes. Swab sub-sample was collected from approximately 12” square surface area of the floor in the Chill Storage Room near the white plastic pallets holding untrimmed Ahi tuna in the Storage Room. FDA observed an employee washing down the area with a water hose and the water splashed onto the fish.
Environmental swab #20 found positive for Listeria welshimiri. Swab sub-sample was collected from the top surface of the white plastic pallet holding Ahi tuna on the floor of the Ahi tuna trimming area of the Processing Room.
Environmental swab #13 found positive for Listeria innocua. Swab sub-sample was collected from the handle and nozzle of a water hose resting on a trash can near the Ahi tuna trimming area in the Processing Room.
Environmental swab #14 found positive for Listeria innocua. Swab sub-sample was collected from the handle of a trash can in the Ahi tuna trimming area in the Processing Room.
Listeria monocytogenes is a pathogenic bacterium that can contaminate foods, resulting in a mild illness called listerial gastroenteritis or a severe, sometimes life threatening, illness called invasive listeriosis. Immune-compromised individuals, the elderly, and unborn fetuses are particularly susceptible to listeriosis. The presence of Listeria monocytogenes in your plant environmental poses a great risk to your ready-to-eat finished products. It is essential that you identify all areas of your facility where Listeria monocytogenes is able to grow and survive and take the necessary corrective actions to control the organism. Listeria innocua and Listeria welshimiri are not considered to be pathogenic (disease causing) bacteria. However, their presence in the environment indicates the possible presence of Listeria monocytogenes, which happened in your case.
The results of our sample analyses related to the presence of Listeria monocytogenes in your plant environment were communicated to your firm via conference call on June 15, 2012. We acknowledge your quick response and your efforts to prevent, eliminate, or reduce the risk of bacterial cross-contamination with your finished, ready-to-eat seafood products. We will verify the effectiveness of your corrective action at the follow-up inspection of your facility.
Please send your reply to the U. S. Food and Drug Administration, Attention: Lawton W. Lum, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have questions regarding any issues in this letter, please contact Compliance Officer Erlinda Figueroa at (510) 337-6795.
Barbara J. Cassens
San Francisco District
cc: Gary T. Ishimoto, President