Sam's Marketing Inc. dba CoCo’s Fish Market 7/21/11
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alamada, CA 94502-7070
UPS OVERNIGHT DELIVERY
July 21, 2011
Our Reference # 3005352998
Peter D.J. Kim, President
Sam’s Marketing Inc., dba CoCo’s Fish Market
100 N. Beretania Street, Suite 173-3
Honolulu, Hawaii 96817
Dear Mr. Kim:
We inspected your seafood processing facility located at 100 N. Beretania St., Suite 173-3, Honolulu, Hawaii between the following dates: March 24 to April 6, 2011. 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 (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 fresh, refrigerated seafood products, including scombroid finfish Tuna and Yellowtail, 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.
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 refrigerated tuna and yellowtail tuna, intended to be consumed raw does not list the food safety hazard of pathogen growth.
2. 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 Tuna and Yellow tail lists a critical limit at the Receiving critical control point of “(b)(4)” that is not adequate to control histamine formation. Your plan does not list that you will monitor internal temperature of the fish at 40 ºF or below and the presence of sufficient ice (i.e., fish adequately surrounded by ice) at the time of delivery. Moreover, on March 25, 2011, our investigator observed that you received raw tuna fish transported on the floor of your non-refrigerated van. The fish were not covered with ice upon receipt and your firm failed to monitor and record the internal temperatures. Please be advised that since your firm receives raw Scrombrotoxin (histamine) forming species of fish, such as tuna and yellowtail, in a non-refrigerated vehicle, the conditions in the vehicle create a high risk for time and temperature abuse during transit.
- Your firm’s HACCP plan for Tuna and Yellow tail, intended to be eaten raw, lists a critical limit of “(b)(4)” at the Finished Product Storage critical control point that is not adequate to control histamine formation. This critical limit does not identify a temperature critical limit value (i.e., 40° F or below and/ or provide indication that the fish will be stored with a sufficient amount of ice continuously surrounding the fish.
Please refer to Chapter 7 of the Fish and Fisheries Products Hazards & Controls Guidance: Fourth Edition for additional information related to the hazard of Scrombrotoxin (Histamine) Formation and appropriate control strategies for receiving and storage of your products.
3. You must implement the recordkeeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the “Finished Product Storage” critical control point to control histamine formation listed in your HACCP plan for Tuna and Yellow tail, intended to be eaten raw.
4. Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate to comply with 21 CFR 123.7(b). However,
a) Your corrective action plan listed at the “Receiving” Critical Control Point in your “Tuna and Yellow tail” intended to be consumed raw HACCP plan to control histamine is not appropriate. Specifically, your corrective action plan does not resolve how the cause of the deviation will be corrected.
b) Your corrective action plan listed at the “Processing” Critical Control Point in your “Tuna and Yellow tail” intended to be consumed raw HACCP plan to control histamine is not appropriate. Specifically, your corrective action plan does not resolve how the cause of the deviation will be corrected.
c) Your corrective action plan listed at the “Finished Product Storage” Critical Control Point in your “Tuna and Yellow tail” intended to be consumed raw HACCP plan to control histamine is not appropriate. Specifically, your corrective action plan does not ensure that unsafe product will not reach consumers and it does not resolve how the cause of the deviation will be corrected.
Please refer to Chapter 7 of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition for guidance regarding corrective actions.
5. 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 CFR 123.11(b). However, your firm did not monitor the following specific 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) Safety of water that comes into contact with food or food contact surfaces, or is used in the manufacturer of ice [21 CFR 123.11(b)(1)]
i) Your firm uses a van to transport exposed raw tuna directly on the van floor which was observed to be dirty and grimy. Our investigator observed that ice removed from the dirty floor of the van was reused to cover fish in a cooler.
ii) Your firm lacks a back-flow prevention device on the hose valve for the hose used to wash down fish, food contact surfaces, and the facility. Our investigator observed this hose stored on the floor and near the floor drain.
B) Condition and cleanliness of food contact surfaces [21 CFR 123.11(b)(2)]
i) On the morning of March 24, 2011, our investigator observed an egregious accumulation of fish scales, grime, blood, and other debris throughout the processing area, including on the cutting table. Although your firm had not scaled any fish that morning, scales were present on the food contact surfaces even though the previous end-of-day sanitation monitoring records reflected that the condition of this area had been acceptable. That morning, your firm had already begun processing tuna into ready-to-eat loins in this inadequately cleaned area.
ii) The cutting boards and a plastic mallet which were being used to process tuna were deeply gouged with dark grime embedded in the surface. The gouges prevent the food contact surfaces from being properly cleaned and sanitized. Also, the condition of the processing table was uneven and damage allowing the pooling of water and fish blood on the food contact surface.
iii) The food contact surfaces of the cart being used to transport raw tuna was made of dirty, gouged plywood which is not an impervious surface and allows the absorption of moisture which facilitates bacterial growth.
iv) The wooden shelves in your cooler used to directly store tuna were deeply gouged and splintered. The shelves are not impervious. Blood was observed dripping from the surfaces.
C) Prevention of cross-contamination [21 CFR 123.11(b)(3)]
i) On at least six occasions during the inspection on March 24, March 25, and April 1, 2011, our Investigator observed your employee drag whole tuna fish directly on and across the processing room floor. The floor surface was damaged and uneven and the standing water on the floor was observed to contain blood, dirt, algae like substance, and caked filth. After dragging the tuna across the floor, your firm continued to process the tuna into a raw ready-to-eat sashimi product.
ii) On March 25, 2011, our investigator observed your employee conduct multiple tasks without washing their hands or changing gloves between tasks. For examples, your employee resumed handling tuna after touching the grimy retail cooler handle.
D) Maintenance of hand washing, hand sanitizing, and toilet facilities [21 CFR 123.11(b)(4)]
i) Your hand washing basin was observed to be filthy with scales, blood, and caked on grime around the handles, which allows clean hands to be re-contaminated.
E) Exclusion of pests from the food plant [21 CFR 123.11(b)(8)]
i) Our investigator observed 5 to 20 live flies land directly on processed ready-to-eat tuna loins and food contact surfaces in the processing room.
6. Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated to comply with 21 CFR 110.35(a). However, on March 24, 2011, our investigator observed the following:
i) Your firm transports the tuna directly on the exposed floor of the van. The doors to the van were observed to contain worn, wet and filthy cloth interiors. Also, our investigator observed that the van floor is cleaned with only water, without any detergent or sanitizers. The broom used to remove the remaining ice and to rinse out the van had been stored in direct contact with the grimy processing room floor of your facility.
7. All persons working in direct contact with food, food contact surfaces, and food-packing materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food to comply with 21 CFR 110.10(b)(8).
i) However, on March 25, our investigator observed a recently smoked cigarette butt lying on the processing floor where the tuna is dragged across.
8. Plant buildings and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-manufacturing purposes to comply with 21 CFR 110.20(b).
i) However, your processing facility lacks a barrier at the upper walls to the ceiling which leads to the outside environment.
ii) The floors of your processing area were extensively worn, with damage surface areas.
9. Rubbish and any offal shall be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, water supplies, and ground surfaces to comply with 21 CFR 110.37(f).
i) However, on 3/24/11 several large, approximately 50 gallon, uncovered trash cans and containers full of fish waste were left in the processing room at ambient temperature overnight. One of the containers was observed to be overflowing with fish waste.
The above violations are not intended to be an all-inclusive list of violations at your firm.
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 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.
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.
Please send your reply to the attention:
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
If you have any questions regarding any issue in this letter, please contact Ms. Almogela at 510-337-6769, or Juliane Jung-Lau, Compliance Officer at 510-337-6793.
Barbara J. Cassens
San Francisco District Director