Inspections, Compliance, Enforcement, and Criminal Investigations
Austin Fish Company
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
December 01, 2009
VIA FEDERAL EXPRESS
James W. Austin, President
Austin Fish Company
3711 South G,roatan Hwy
Nags Head, NC 27959
Dear Mr. Austin:
We inspected your seafood processing facility, located at 3711 South Croatan Hwy, Nags Head, NC 27959 on September 17 - 18, 2009. 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). IIi 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 Bluefish, Spanish Mackerel, Tuna, Shad, King Mackerel, Amberjack, Dolphin (Mahi Mahi), and Wahoo, 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 plan for Bluefish, Spanish Mackerel, Tuna, Shad, King Mackerel, Amberjack, Dolphin (Mahi Mahi), and Wahoo lists critical limits, "Check that fish arrive from fishermen on ice at proper temp of (b)(4) or below" and "Keep fish stored on ice and under refrigeration", at "on-arrival" critical control point that is not adequate to control histamine formation in scombroid species fish while onboard the harvest vessel.
• Your critical limit does not ensure the control of histamine formation from the time of
death until the fish are placed on ice or other form of refrigeration. We recommend that
all lots of fish received are accompanied by harvest vessel records which demonstrate
that fish are placed in ice or other form of refrigeration at 40°F within 12 hours of death,
or placed in a form of refrigeration at 50°F or less within 9 hours of death. Alternatively,
you may also consider histamine testing for each incoming lot to control histamine
formation. Chapter 7 of the Fish and Fisheries Products Hazards and Controls Guidance
can provide guidance in determining which method is best suited to your process and the
critical limits and monitoring procedures FDA considers adequate to control the hazard of
• Your HACCP Plan fails to list the critical limit(s) of the internal temperature of fish
received from harvest vessels. We recommend if fish are delivered in less than 12 hours
after death, an internal temperature below ambient air and water temperatures; or if the
fish are delivered 12 or more hours after death an internal temperature of 50°F or below;
or if the fish are delivered 24 or more hours after death, an internal temperature of 40°F
• Your HACCP Plan fails to lists the critical limit(s) for the amount of decomposition in
the incoming lot of fish. We recommend a sensory examination of a representative
sample of fish shows no more than 2.5% decomposition in the sample.
Once you have established critical limits to control histamine formation upon receipt, your
HACCP plan for Bluefish, Spanish Mackerel, Tuna, Shad, King Mackerel, Amberjack, Dolphin
(Mahi Mahi), and Wahoo must also include appropriate monitoring procedures and record
keeping, at this critical control point.
2. 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 Bluefish, Spanish Mackerel, Tuna, Shad, King Mackerel, Amberjack, Dolphin (Mahi Mahi), and Wahoo does not list the critical control point of refrigerated cooler storage for controlling the food safety hazard of histamine formation.
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 the Food and Drug Administration, Attention: Derek Price, Compliance Officer, 60 8th Street, N.E., Atlanta, GA 30309. If you have questions regarding any issues in this letter, please contact Derek Price at 404-253-2277.
Atlanta District Director