Public Health Service
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700
Alameda, CA 94501-7070
Telephone: (510) 337-6700
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUIRED
WARNING LETTER
October 30, 2012
Our Reference # 3000203754
Joseph A. Caito, President
Caito Fisheries, Inc.
19400 Harbor Avenue
Fort Bragg, CA 95437
Dear Mr. Caito:
We inspected your seafood processing facility located at Pier 45 Shed B-6/B-7, San Francisco, CA 94133 between the following dates: August 22 to September 4, 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 seafood products, including fresh, refrigerated scombroid finfish Albacore Tuna, fresh, refrigerated raw Dungeness Crab, and refrigerated, ready-to-eat cooked Dungeness Crab, 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 acknowledge the receipt of your letter, dated September 25, 2012, in response to the form FDA 483, Inspectional Observations, issued to you on September 4, 2012. However, your response is not adequate in that the submitted HACCP plans were incomplete, containing missing pages. To determine the adequacy of your response, we will need to review your HACCP plans in their entirety. The deviations listed in this letter are based on the inspection and our review of your firm’s HACCP Plans for fresh, refrigerated Albacore Tuna and fresh, refrigerated raw Dungeness Crab that were collected during the inspection.
Your significant violations are as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for the receiving and storage of ready-to-eat cooked Dungeness Crab to control the food safety hazard of pathogen growth and toxin formation.
Please refer to Chapter 12 of the Fish Guide for additional information related to Pathogenic Bacteria and Toxin Formation for appropriate control strategies 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 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 plans for Albacore Tuna and Dungeness Crab do not list the food safety hazard of undeclared allergens for your finfish and crustacean shellfish.
Please refer to Chapter 19 (Undeclared Major Food Allergens) of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition (the Fish Guide) for guidance in determining the appropriate controls for your process.
3. 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,
a. your firm’s HACCP plan for Dungeness Crab does not list the critical control point of Finished Product Storage for controlling the food safety hazard of pathogenic bacteria growth and toxin formation, and
b. your firm’s HACCP plan for Fresh Albacore Tuna does not list the critical control point of Finished Product Storage for controlling the food safety hazard of histamine formation.
4. 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 Albacore Tuna lists a critical limit of “(b)(4)” at the “Receiving” critical control point that is not adequate to control histamine formation.
To control histamine formation in scombrotoxin-forming fish received directly from the harvest vessel, FDA recommends critical limits which include three components: harvest vessel records (in lieu of histamine testing), sensory examination, and the internal temperature measurements for fish that are received fresh as recommended on page 125-126 of the Fish Guide. Specifically:
- All scombrotoxin-forming fish lots received are accompanied by harvest vessel records that show specific time/temperature parameters (i.e. critical limits). For example, records showing fish exposed to air and water temperatures of 83°F or less were in ice, or in refrigerated seawater, ice slurry, or brine of 40°F or less, as soon as possible after harvest, but not longer than 9 hours from the time of death.
- Conducting sensory examination at receipt. We recommend that primary processors conduct the evaluation on 118 fish in the lot or all of the fish if the lot is less than 118 fish. The critical limit for acceptance of the entire lot should be 2.5% decomposition. For example, no more than 2 fish in a sample of 118 may show signs of decomposition.
- Internal temperature measurements of fish at receipt to demonstrate that the fish were properly chilled while onboard the vessel. Your critical limit must identify a specific parameter which must be met. For example, for fish held iced or refrigerated (not frozen) onboard the vessel 24 or more hours after death, the internal temperature should be 40°F or below; or for fish held iced or refrigerated onboard the vessel from 15 to less than 24 hours after death, the internal temperature should be 50°F or below.
For guidance in establishing adequate monitoring procedures, corrective action plan, verification procedures, and record-keeping that are applicable to your critical limits as a primary processor to control histamine formation, please refer to Chapter 7 of the Fish Guide.
To control histamine formation in scombrotoxin-forming fish as a secondary processor, you must have adequate transit control of fish delivered to your facility. Your critical limit as specified on your HACCP plan is not adequate. Our inspection found that your firm is monitoring (b)(4) received at your facility as a secondary receiver. If you choose this control strategy, we recommend that your firm include in your HACCP plan the appropriate critical limit that reflects your operation. For fish delivered under ice, FDA recommends you ensure the fish are completely surrounded by ice at the time of delivery. For fish delivered under ice on an open-bed truck, FDA recommends the fish are stored completely surrounded by ice AND the internal temperature of the fish at the time of delivery is 40ºF or below (taken for a representative number of fish in the lot.)
Please refer to Chapter 7 of the Fish Guide for additional information related to the hazard of Scrombrotoxin (Histamine) Formation and appropriate control strategies for receiving and storing of your products according to your operations.
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 copies of any revised HACCP plans, at least five (5) product days worth of HACCP monitoring records to demonstrate that you have implemented the revised plans, any verification records, and 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.
Sincerely,
/S/
Barbara J. Cassens
San Francisco District Director
cc: Michael G. Gutierrez, Manager
Caito Fisheries, Inc.
P.O. Box 2415
San Francisco, A 94126
Page Last Updated: 11/08/2012
