Inspections, Compliance, Enforcement, and Criminal Investigations
Pierpont Seafood 06-Nov-06
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REOUESTED
November 6, 2006
Alfred L. Ballabio, Owner
1449 Spinnaker Drive, Suite D
Ventura, CA 93001
Dear Mr. Ballabio:
We inspected your seafood processing facility, located at 1449 Spinnaker Drive, Suite D, Ventura, California 93001 on October 10-11, 2006. 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 fresh Yellowfin tuna and other histamine-forming fish 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 violation was as follows:
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 any 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 fresh [redacted] histamine-forming fish to control the food safety hazard of histamine formation.
We may take further action if you do not promptly correct this violation. 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.
We acknowledge your letter (undated) that we received on October 23, 2006, in which you indicate. that your will no longer process tuna or any other species with a histamine hazard [redacted]; we respectfully request that you reaffirm your commitment to discontinue processing these types of fishery products if that is indeed your intention to do so. Even so, you should be aware that other provisions of 21 CFR 123 (i.e. the seafood HACCP regulation) still apply to your firm, including sanitation monitoring, and performing hazard analyses for all remaining fish and fishery products that you process at the inspected location. If these hazard analyses determine that significant food safety hazard(s) are reasonably likely to occur for any of these products, then HACCP plan(s) must be developed and implemented for them in accordance with 21 CFR 123.
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.
Your written reply should be addressed to:
Pamela B. Schweikert, Director, Compliance Branch
U. S. Food and Drug Administration
Irvine, California 92612-2445
If you have questions regarding any issue in this letter, please contact Robert McNab, Compliance Officer at (949) 608-4409.
Alonza E. Cruse
CC: State of California, DHS/FDB
Department of Health Services
Food and Drug Branch
P.O. Box 997413, MS-7602
Sacramento, CA 95899-7413