J. DeLuca Fish Company, Inc. 12/9/11
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Los Angeles District|
Irvine, CA 92612-2506
Telephone (949) 608-2900
RETURN RECEIPT REQUESTED
December 9, 2011
John M. DeLuca, President
J. DeLuca Fish Company, Inc
2204 Signal Place
San Pedro, CA 90731-7227
Dear Mr. DeLuca,
We inspected your seafood processing facility, located at 2204 Signal Place, San Pedro, CA 90731 which concluded on September 1, 2011.
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 fish or fishery products 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
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 “(b)(4)" identifies the critical limit of "Fish placed in (b)(4) or less within (b)(4) hours of death. Placed in refrigerated (b)(4) or less within (b)(4) hours of death and chilling to bring the internal temperature of the fish to (b)(4)..." at the "(b)(4)" CCP. These critical limits are associated with the handling of the fish onboard the harvest vessels and alone are not adequate for a primary processor receiving the fish directly from the harvest vessels, when using the harvest vessel record control strategy to control the significant hazard of "Histamines". The critical limit for the HACCP Plan B should identify harvest vessel records as the strategy, and include sensory examination of at least 118 fish in the lot or all the fish in the lot when there are less than 118 fish at receiving and conduct adequate internal temperature monitoring to ensure that the fish offloaded from day boats have been adequately handled to prevent histamine development. For additional information related to the harvest vessel (i.e., record) control strategy please see pages 125 to 131 in the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance.
2. You must have a HACCP plan that list monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123.6(c)(4). However:
A. Your firm’s HACCP “(b)(4)" does not list adequate monitoring procedures at the “(b)(4)” CCP adequate to control “Histamines”. Specifically your plan identifies the monitoring of "Harvest vessels records and receiving fish temperature" via a "(b)(4)" for every load at the "(b)(4)" CCP. This monitoring procedure does not indicate how the harvest vessel records and receiving fish temperature will be monitored, for example FDA recommends a visual review of the harvest vessel records and a thermometer to measure the temperature of the fish at receiving as well as the number of fish that will be measured to ensure that the critical limit is met at this CCP.
B. In addition, your firm’s HACCP “(b)(4)” does not list adequate monitoring procedures at the “(b)(4)” CCP adequate to control “Histamines”. Your plan lists that you will monitor cooler temperatures “(b)(4)” during operation hours. This is not adequate to ensure that the fish are continuously maintained at adequate temperatures during storage to control histamine formation. FDA recommends that when cooler temperatures are the primary control strategy (i.e., rather than ice) that firms use equipment capable of continuously monitoring and recording cooler storage temperature on a 24 hour a day/7 day a week basis. Moreover, we note that your corrective actions at this CCP include reference to fish exposed to elevated temperatures within (b)(4) hour intervals. However, a (b)(4) check of the temperatures (i.e., every (b)(4) hours) will not provide the temperature information necessary to base a corrective action that involves temperature excursions on (b)(4) hour intervals.
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.
Please send your reply to:
Food and Drug Administration,
Attention: Daniel Solis
Director, Import Operations Branch
Los Angeles District
222 West 6th Street, Suite 700
San Pedro, CA 90731
If you have questions regarding any issues in this letter, please contact Carla Fernandez Borges, Compliance Officer at (310) 971-2373.
Alonza E. Cruse, Director
Los Angeles District