Inspections, Compliance, Enforcement, and Criminal Investigations
Monarch Seafoods, Inc. 9/10/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUIRED
September 10, 2012
Our Reference # 2938878
Thomas T. Mukaigawa, President
Monarch Seafoods, Inc.
515 Kalihi Street
Honolulu, Hawaii 96819
Dear Mr. Mukaigawa:
We inspected your seafood processing facility located at 515 Kalihi Street, Honolulu, Hawaii between the following dates: June 11 to June 14, 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 fresh, refrigerated seafood products, including scombroid finfish 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.
On June 29, 2012, we received your letter in response to the form FDA 483, Inspectional Observations, issued to you on June 14, 2012. Your 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 firm’s HACCP plan for Tuna, entitled “Fresh Fish: dressed, loined, steaked (histamine forming fish species including tuna spp., mahimahi, marlin, wahoo, etc.)” that was collected during the inspection.
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 Tuna does not list the food safety hazards of
• pathogen growth and toxin formation as a result of time/temperature abuse for fish intended for raw consumption and
• the food safety hazard of undeclared allergens for all your fish (i.e., fish protein).
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.
Refer to Chapters 12 (Pathogenic Bacteria) and 19 (Undeclared Major Food Allergens) of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition for guidance in determining the appropriate controls for your process.
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’s HACCP plan for Tuna lists a critical limit of “1) (b)(4)” at the “Receiving (b)(4)” critical control point that is not adequate to control histamine formation. Our investigator observed that your tuna is received at your facility in non-refrigerated vehicles from the (b)(4) covered in ice. As such, your firm needs to include both internal temperature monitoring AND visually observing that the fish are completely surround by ice at the time of receipt; or that the fish are held under adequate chemical cooling media such as gel packs for fish held with chemical coolants rather than ice. This applies to all shipments of scromboid finfish; not only for imported shipments, in order to adequately control histamine formation.
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 storing of your products.
3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However:
a) Your firm did not follow the monitoring procedure and frequency of monitoring the “(b)(4)” for “(b)(4)” at your “Receiving” critical control point to control histamine formation as listed in your HACCP plan for Tuna. Specifically, our inspection found that on May 21, 2012, your firm received at least three headed and gutted tuna and failed to follow your procedures and frequencies. Furthermore, your firm did not monitor for the “(b)(4)” for each fish as listed in your HACCP plan.
b) Your firm did not follow the monitoring procedure and frequency for monitoring “(b)(4)” using the a “(b)(4)” by “(b)(4)” at your “Cold storage” critical control point to control histamine formation as listed in your HACCP plan for Tuna. Our investigator observed that your firm, in fact, had no continuous data logger in use at the time of the inspection.
We acknowledge in your response letter that you have now implemented the use of a (b)(4). We will verify this corrective action during our next inspection. We suggest that you establish a record keeping system and make the appropriate updates to your HACCP plan to reflect the maintenance of the records related to the monitoring at this cold storage critical control point. In addition, we recommend making a visual check of the data logger record and of the equipment itself.
4. 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, your firm did not record monitoring observations at the “Receiving” critical control point to control histamine formation as listed in your HACCP plan for Tuna. Specifically, our inspection found that between the dates May 25 to June 8, 2012, your firm received multiple shipments of tuna and failed to have receiving records documenting the monitoring of internal temperatures for each shipment of fish upon receipt.
We acknowledge your response letter stating that your employee had taken monitoring records home by accident and you will provide information to us once the employee returns in July. However, you had informed our investigator that your sole employee responsible for HACCP plan implementation was absent during the end of May and had not yet returned to work at the time of our inspection. To date, we have not received any follow-up records. And your response did not include how you will ensure this problem will not recur.
5. 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, your corrective action plan for Tuna to control histamine formation at the “Receiving” Critical Control Point listed as “(b)(4).” is not appropriate because your firm will not have the critical limit parameters necessary to make an evaluation of the time and temperatures above 40 degrees F. Specifically, your firm is not continuously monitoring the temperature of the fish for the duration of the transit period to your facility. Consequently, your firm will not have the “time” parameter to reflect how long the fish were exposed to temperatures above 40 degrees F. Additionally, your corrective action plan does not resolve how the cause of the deviation will be corrected.
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.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s 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.
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:
Lawton W. Lum
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 Juliane Jung-Lau, Compliance Officer at 510-337-6793.
Barbara J. Cassens
San Francisco District Director