Inspections, Compliance, Enforcement, and Criminal Investigations

Nobuo T. Hawaii Inc. 1/3/14

  

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, GA 94501-7070
Telephone: (510) 337-6700 

 

WARNING LETTER
 
                                                                                                           
UNITED PARCEL SERVICE                                                         
SIGNATURE REQUIRED
 
January 3, 2014
 
Mr. Nobuo K. Tsuchiya, President
Nobuo T. Hawaii Incorporated
1020 Auahi Street
Honolulu, Hawaii 96814
 
                                                                                               
Dear Mr. Tsuchiya:
 
We inspected your seafood processing facility, located at 1020 Auahi Street, Honolulu, Hawaii 96813 on September 23-28, 2013.  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 refrigerated histamine forming fish, including your fresh raw–ready-to-eat Ahi 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 received your response dated October 14, 2013 to the FDA 483 List of Observations. The following list of violations is based on our review of your revised HACCP plan and documents submitted in your October 14 response, in addition to the observations we made during our inspection conducted September 23-28, 2013.

Your significant violations were as follows
 
1.    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, dated October 4, 2013, for “(b)(4)” lists a critical limit at the Receiving and Cold Storage CCPs of, “(b)(4). Your critical limits are not adequate to control the hazard of Pathogenic Bacteria Growth and Toxin Formation as a Result of Time and Temperature Abuse. While well-designed sanitation programs (prerequisite programs) will minimize the introduction of pathogenic bacteria, in most cases it is not reasonable to assume that they will fully prevent the introduction of pathogenic bacteria. Please refer to Chapter 12 of the Fish and Fishery Products Hazards and Control Guidance (The Guide), Fourth Edition for additional information.

Also, the critical limits do not address specific time or temperature controls. A critical limit should directly relate to the parameter that you will be monitoring, such as “temperature control”. While your controls for the hazard of “Histamine” at the Receiving and Cold Storage CCPs may be considered adequate to also control Pathogenic Bacteria Growth and Toxin Formation as a Result of Time and Temperature Abuse, the differences in recommended exposure times for histamines vs. various pathogens may become relevant when considering corrective actions (see The Guide, Table A-2, page 421). 
 
2.     You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm’s HACCP plan for “(b)(4)” lists a monitoring procedures at the Packing/Wrapping/Labeling CCP that is not adequate to control the hazard of allergens. Please note that Chapter 19 of The Guide recommends monitoring labels on finished product packages to ensure they accurately list the market names of the species of fish.
 
3.    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 for “(b)(4)” at the Receiving and Cold Storage CCPs to control histamine are not appropriate. Specifically, your corrective action describes the cumulative time needed to regain control of temperature as “(b)(4)”. Scrombroid toxin fish that has not been frozen or processed sufficiently to destroy scrombroid toxin forming bacteria should not be exposed to temperatures above 40F for more than 4 hours cumulatively, if anyportion of that time is at temperatures above 70F; or, for more than 8 hours cumulatively, as long as no portion of that time is at temperatures above 70F. See Table 7-2 in The Guide for more information.
 
4.    You must take an appropriate action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control histamine when your process for “(b)(4)” deviated your critical limit at the Cold Storage CCP.  According to your temperature log provided to our investigators, on 9/24/2013,  the temperature for “(b)(4)” was logged at “(b)(4)” at 11:00AM and 1:00PM. No corrective action was logged according to your records and you were unable to provide any documentation that this deviation was investigated or corrected.
 
We acknowledge that the “(b)(4),” which you provided in your October 14 response, demonstrates that your firm took appropriate corrective actions to temperature deviations between the dates of 10/05/13 – 10/11/13. We will evaluate the adequacy and sustainability of your corrections during our next inspection.
 
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 condition and cleanliness of food contact surfaces as required by 21CFR 123.11(b)(2), prevention of cross contamination, as required by 21CFR 123.11 (b)(3), or the exclusion of pests from the food plant, as required by 21CFR 123.11(b)(8)  with sufficient frequency as evidenced by the following:
 
a.    Your employees were observed handling raw sushi-grade ahi tuna fish using hooks which were stored along a wall ledge caked with debris. Your employees then prepared and weighed the sushi-grade ahi tuna on a gouged cutting board, stained with debris. The employees did not wash or sanitize the hooks or cutting board before use or during the entire time our investigators were present. 
 
b.     Our investigators observed employees routinely placing sushi-grade ahi tuna onto trays stored directly on the wet, pitted concrete processing floor without cleaning or sanitizing the trays before use. The storage cooler walls were observed stained with debris which appeared to be dirt, flesh, and blood from previously processed fish. Fresh gilled and gutted ahi was seen stored in direct contact with these stained and dirty walls.
 
c.    Our investigators observed several flies and birds throughout the receiving area of the facility.
 
We acknowledge that in your October 14 response, you provided documentation demonstrating corrections to the observations above. These corrections included, but were not limited to the following; new hooks and cutting boards; repaired and cleaned walls, ceilings, and plastic strip curtains; new storage racks for processing trays; employee HACCP Sanitation training records dated 10/12/2013. We will evaluate the adequacy and sustainability of your corrective actions during our next inspection.
 
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.
 
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. A re-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 means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-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.
 
Please send your reply to the Food and Drug Administration, Attention: 

Lawton W. Lum
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94052
 
Refer to the Unique Identification Number CMS case #415285 when replying.
 
If you have any questions about the content of this letter please contact Ms. Aleta T. Flores, Compliance Officer at (510) 337-6821.
 
 
Sincerely,
/S/ 
Kathleen M. Lewis, J.D.
District Director 

Page Last Updated: 01/09/2014
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