Inspections, Compliance, Enforcement, and Criminal Investigations
Caito Fisheries, Inc. 4/30/14
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
April 30, 2014
RETURN RECEIPT REQUESTED
Joseph A. Caito, President
Caito Fisheries, Inc.
P.O. Box 1370
Fort Bragg, CA 95437
Dear Mr. Caito:
We inspected your seafood processing facility, located at Fort Bragg, CA on February 24, 2014 through February 26, 2014. 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 Dungeness crab is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby itmay 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 a response from John Caito dated March 17, 2014 concerning our investigator’s Observations noted on the Form FDA 483, List of Inspectional Observations that was issued to John B. Caito. We address this response below, in relation to each of the noted violations.
Your significant violations were as follows:
1) 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 plan for Fresh Cooked Dungeness Crab Products does not list the critical control point of receiving for controlling the food safety hazard(s) of pathogen growth of your cooked crab from your San Francisco, CA location.
We have reviewed your response in which you indicate that you have implemented a receiving critical control point for Fresh Cooked Dungeness crab received from Oregon & Washington. Your response is inadequate because your HACCP Plan for Fresh Cooked Dungeness Crab Products included in your response does not include the change you describe. Additionally, Dungeness crab season has not open since our inspection and you did not include processing records for our review.
2) 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 Fresh Cooked Dungeness Crab Products:
a. does not list a critical limit at the Finished product Labeling critical control point to control Clostridium botulinum; and
b. lists the following critical limits that are not adequate to control Clostridium botulinum for your vacuum-packaged crab:
i. To be stored in ice at 40 degrees or below within 4 hours of packing, at the Reduced oxygen of packaging crab meat critical control point; and
ii. Cooler temperature not to exceed 40°F at the Cooler Storage Finished Product; critical control point.
We have reviewed your response in which you indicate that you have changed the critical limit at the Reduced oxygen of packaging crab meat critical control point; and have added a second critical control point at labeling to ensure that all frozen products contain a Keep Frozen statement on the label. Your response is inadequate because your HACCP Plan for Fresh Cooked Dungeness Crab Products included in your response is incomplete and does not include the Reduced oxygen of packaging crab meat critical control point change you describe. The addition of Frozen Labeling critical control point appears to be adequate. We will evaluate the implementation of this critical control point during our next inspection.
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, your firm did not follow the monitoring procedures of Continuous with visual and record twice daily during normal working hours at the Cooler Storage Finished Product critical control point to control pathogen growth listed in your HACCP plan for Fresh Cooked Dungeness Crab Products.
We have reviewed your response in which you indicate that you are researching continuous monitoring data recorders. The response is inadequate because you have made no changes or corrections to the monitoring procedures.
4) 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 required for the processing of Fresh Cooked Dungeness Crab Products from December 29, 2013 through January 4, 2014 and February 16, 2014 through February 22,2014 for the following:
a. safety of water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice; and
b. control of employee health conditions that could result in the microbiological contamination of food packaging materials, and food contact surfaces.
We have reviewed your response in which you indicate that water is monitored daily and attached daily sanitation form. Your response is inadequate because the daily sanitation form included does not show how you monitor the adequacy and safety of the water used for the production of ice, nor does it include monitoring of employee health conditions.
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 FFD&C 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 FFD&C 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 FFD&C 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, Compliance Branch, 1431 Harbor Bay Parkway, Alameda, CA 94501. If you have questions regarding any issue in this letter, please contact Sergio Chavez at (510) 337-6886 or Sergio.Chavez@fda.hhs.gov.
Please reference number CMS 428769 in your response.
Kathleen M. Lewis, J.D.
San Francisco District Office