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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Jin's Seafood Enterprise Inc., dba Choi's Fish Market 8/1/11

  

Department of Health and Human Services' logoDepartment 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 

UPS OVERNIGHT DELIVERY
SIGNATURE REQUIRED

WARNING LETTER

August 1, 2011

Our Reference# 3005355711

Dae Young Hwang, President
Jin's Seafood Enterprise Inc., dba Choi's Fish Market
100 N. Beretania Street, Suite 173-4
Honolulu, Hawaii 96817

Dear Mr. Hwang:

We inspected your seafood processing facility located at 100 N. Beretania St., Suite 173-4, 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 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 seafood products, including scombroid finfish Tuna and Mahi Mahi, 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 offish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (b). However,

a) Your firm does not have a HACCP plan for refrigerated Mahi Mahi and other scrombrotoxin producing species intended to be cooked by the end user to control the food safety hazard of histamine formation. Please be advised that in accordance with 21 CFR 123.6(b)(2) firms may group kinds of fish and fishery products together if the food safety hazards, critical control points, critical limits, and procedures requires to be identified and performed are identical.

b) Your firm does not have a HACCP plan for refrigerated Salmon intended to be consumed raw to control the food safety hazards of pathogen growth and parasites in any species that pose a risk for parasites.

c) Your firm does not have a HACCP plan for refrigerated Tuna intended to be consumed raw to control the food safety hazards of pathogen growth, parasites in any species that pose a risk for parasites, and histamine formation.

Chapter 12 of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition can provide guidance in determining the appropriate ·controls for your process.

Once you have conducted a hazard analysis for your seafood products, your HACCP plan must, at a minimum, list hazards that are reasonably likely to occur, and include appropriate critical control points, critical limits, monitoring procedures, recordkeeping activities, etc., to ensure that the food safety hazards are controlled to comply with 21 CFR 123.6(c).

2. You must have a HACCP plan that, at a minimum, lists the critical limit 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 does not have a HACCP plan for refrigerated Mahi Mahi and other scrombrotoxin producing species intended to be cooked by the end user to control the food safety hazard of histamine formation. Please be advised that in accordance with 21 CFR 123.6(b)(2) firms may group kinds offish and fishery products together if the food safety hazards, critical control points, critical limits, and procedures requires to be identified and performed are identical.

3. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c) (7). However,

a) Your firm did not record monitoring observations at the "Receiving (b)(4)" critical control point to control histamine formation listed in your HACCP plan for "Ahi processed for cooking." Our inspection discovered that your firm has stopped documenting or maintaining records for the receipt offish as of November 2, 2010.

On March 24, 2011, you informed our investigator that your firm has stopped documenting the internal temperatures of fish received.

b) 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 ''Ahi processed for cooking." Your HACCP plan lists monitoring procedures of "(b)(4)" through "(b)(4)" to ensure the chill room temperature is not above 40 °F but during the inspection your finished product storage cooler was not equipped with a continuous monitoring device.

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 for Tuna to control histamine formation at the "Receiving (b)(4)" Critical Control Point of (b)(4)" is not appropriate. Specifically, this corrective action plan does not resolve how the cause of the deviation will be corrected.

b) Your corrective action plan for Tuna to control histamine formation at the (b)(4) "Critical Control Point of (b)(4)" is not appropriate. Specifically, this corrective action plan does not resolve how the cause of the deviation will be corrected.

c) Your corrective action plan for Tuna to control histamine formation at the "Finished product Storage" Critical Control Point of (b)(4)" is not appropriate. Specifically, this 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 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.

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 123.1l(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)]

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 in standing-water.

B) Condition and cleanliness of food contact surfaces [21 CFR 123.11(b)(2)]

i) The cutting boards and (b)(4) which were being used to process tuna were deeply gouged and dirty. The gouges prevent the food contact surfaces from being properly cleaned and sanitized.

ii) The processing table was uneven and damaged allowing the pooling of water and fish blood on the table's food contact surface.

iii) The food contact surfaces of the cart being used to transport raw tuna was made of dirty, gouged porous (b)(4). The gouges and porous nature of the material prevent the food contact surfaces from being properly cleaned and sanitized. Additionally, the wood handles on the gaffs used to move tuna were deeply gouged and worn.

iv) The wooden shelves in your cooler used to directly store tuna were deeply gouged and a green algae-like substance was observed on the shelves.

C) Prevention of cross-contamination [21 CFR 123.11(b)(3)]

i) On at least four occasions during the inspection on March 24 and March 25, 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, which contained grimy, filthy, and standing water.

ii) Your firm processed the tuna into loins intended for ready-to-eat sasbimi on a pallet in direct contact with the processing room floor.

iii) A hose, in direct contact with the processing room floor, was observed rinsing a pallet, used to process tuna, and the water splashed from the floor onto the pallet.

iv) Our investigator observed that raw tuna were lying directly on the wet, filthy, damaged cement floor of your walk-in cooler. Some parts of the tuna fish were in direct contact with the floor drain, which was clogged with fish debris and filth.

v) Your firm transports tuna directly on the non-refrigerated van floor. Our investigator observed the van floor to be filthy after being rinsed with water. The van does not receive any additional cleaning or sanitizing after being rinsed with water.

D) 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.

ii) Our investigator observed alive cockroach in close proximity to the location where raw, ready-to-eat tuna loins were being processed in the processing room.

6. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11 (c).

However, your firm did not maintain sanitation monitoring records and sanitation correction records for the maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging materials, and food contact surfaces from adulteration with contaminants, proper labeling, storage, and use of toxic compounds, and control of employee health conditions required for the processing of your refrigerated Ahi Tuna intended to be consumed raw. Our inspection found that you stopped maintaining sanitation control records in November 2010.

7. 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) The cement floors of your processing area were extensively worn and pitted and contained filthy standing water.

ii) Your firm's refrigerated storage cooler was observed to contain rusty walls and a rusty door.

iii) Your retail coolers used to store processed ready to eat fish were caked with fish blood and grime on the sliding glass windows.

iv) Your firm uses a van to transport tuna directly on the van floor. The doors to the van were observed to contain worn, wet, and filthy cloth interiors.

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:

Darlene Almogela
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. Almoge1a at 510-337-6769.

Sincerely,

/s/

Barbara J. Cassens
San Francisco District Director