Inspections, Compliance, Enforcement, and Criminal Investigations
HKH JVC LLC. 11/8/12
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. 1000522876
November 8, 2012
Thomas J. Kraft, President
HKH JVC LLC
1535 Colburn Street
Honolulu, Hawaii 96816
Dear Mr. Kraft:
We inspected your seafood processing facility, HKH JVC LLC, located at 1535 Colburn Street, Honolulu, Hawaii, on August 21, 22, and 24, 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 (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 refrigerated, vacuum packaged, ready-to-eat hot smoked tuna and refrigerated, histamine forming fish including tuna, mahimahi, and marlin, 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.
At the close of our inspection, the investigator provided (b)(4) General Manager, with the form FDA 483, which presents his evaluation of your firm’s performance regarding various aspects of the HACCP requirements. We attached a copy of the FDA 483 for your reference.
The deviations listed in this letter are based on the inspection and our evaluation of your firm’s HACCP plans, signed and dated 5-12-11 and 5-12-12, which revealed the following significant violations:
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 “Hot Smoked fish, refrigerated” does not list the food safety hazard of histamine formation in tuna as a result of time/temperature abuse that occurs at successive processing steps, i.e., thawing and brining, prior to the hot smoking step.
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 plans for “Fish, fresh, processed (histamine-forming) vacuum packed 10K (loin, steak)” and “Hot Smoked fish, refrigerated” do not list the critical control point of Finished Product Labeling for controlling the food safety hazard of allergens.
We acknowledge that your firm considered allergens as a potential hazard likely to occur and indicated that the preventive measure will be addressed at your (b)(4) step. However, at the (b)(4) step of your Hazard Analysis Worksheet, you did not consider this step as a critical control point to control allergens. You justified your decision by indicating that the allergens are listed on the (b)(4).
FDA has identified finfish as a major allergen, which is a food safety hazard that is likely to occur and must be included in your HACCP plan. To establish the appropriate critical limits, monitoring procedures, corrective actions, verification, and record-keeping system, please refer to the Chapter 19 of 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 “Fish, fresh, processed (histamine-forming) vacuum packed 10K (loin, steak” lists a critical limit (b)(4) at the Receiving critical control point that is not adequate to control histamine formation and pathogen growth and toxin formation including Clostridium botulinum toxin. For fish delivered under chemical cooling media such as gel packs, FDA recommends that there is an adequate quantity of cooling media that remain frozen to have maintained product at an internal temperature of 40°F or below throughout transit.
- your firm’s HACCP plans for “Fish, fresh, processed (histamine-forming) vacuum packed 10K (loin, steak)” and “Hot Smoked fish, refrigerated” list a critical limit (b)(4) at the Chill Storage critical control point that is not adequate to control histamine formation and pathogen growth and toxin formation including Clostridium botulinum toxin. For refrigerated storage, 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 exposure that the product experiences. The cumulative exposure for each product would then need to be determined prior to shipping. If you choose this approach the cumulative exposure to temperatures above 40°F should include time during transit, refrigerated storage, and refrigerated and unrefrigerated processing.
To establish the appropriate monitoring procedures, corrective actions, verification, and record-keeping system in order to meet your critical limits, please refer to the Chapters 7 and 13 of the 4th Edition of the HACCP Guide.
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 “Hot Smoked fish, refrigerated” lists a monitoring procedure (b)(4) at the Smoke critical control point that is not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin. FDA recommends monitoring the internal temperature at the thickest portion of three of the largest fish in the smoking chamber using a continuous temperature-recording device (e.g., a recording thermometer) equipped with three temperature-sensing probes.
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 and the seafood HACCP regulation (21 CFR Part 123). 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.
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