Inspections, Compliance, Enforcement, and Criminal Investigations
Atlantic Cape Fisheries, Inc. 24-Oct-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Waterview Corporate Center
10 Watewiew Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 526-6008
RETURN RECEIPT REQUESTED
October 24, 2001
File # 02-NWJ-06
Mr. Daniel Cohen
Atlantic Cape Fisheries, Inc.
985 Ocean Drive
Cape May, NJ 08204
Dear Mr. Cohen:
We inspected your firm, located at 985 Ocean Drive, Cape May, New Jersey on July 26-30, 2001 and found that you have serious deviations from the Seafood HACCP regulations (21 CFR 123). These deviations, some of which were previously brought to your attention, cause your fresh bluefish to be in violation of section 402(a)(4) of the Federal Food Drug & Cosmetic Act (the Act). You can find this Act and the Seafood HACCP regulations through links in FDA?s home page at www.fda.gov.
The deviations were as follows:
1. You must have a HACCP plan that lists the critical limits that must be met to comply with 21 CFR 123.6(c)(3). However, your HACCP plan for histamine?producing fish does not list adequate critical limits at the receiving critical control point. FDA recommends that a sensory examination of the fish should be conducted in addition to internal temperature and harvest vessel controls to control histamine formation at receipt. A representative sample of histamine-producing fish should be examined from each lot to show that no more than 2.5% of the fish in the sample are decomposed. This provides an indication of the level of time and temperature abuse that the fish may have been exposed to that could result in histamine formation. While your "Fresh Pack-out" records suggest that you include an examination for decomposition at some level, this should become an integral part of your HACCP plan, including critical limits that must be met.
During your discussion with the FDA investigator, you mentioned the possibility of conducting histamine testing to control the histamine hazard when receiving bluefish.
FDA accepts appropriate histamine testing at receipt in lieu of proper harvest vessel information. However, internal temperature measurements and sensory examinations should still be included as controls when histamine testing is incorporated.
2. You must have a HACCP plan that lists monitoring procedures for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm?s HACCP plan for histamine-producing fish lists monitoring procedures at the receiving critical control point that are not adequate to control histamine formation.
a. The temperature measurement of one fish per pen from a vessel, especially when only one pen may contain the histamine-producing fish does not provide sufficient indication that the fish were handled in a manner to prevent the formation of histamine. FDA recommends that internal temperatures should be measured on a minimum of one fish per 1000 pounds of histamine-producing species when receiving less than 10 tons of fish. And, at a minimum, measure the internal temperature of 12 of the largest histamine-producing fish in each specie lot; or all of the fish if receiving less than 12 fish.
b. Your HACCP plan does not list a monitoring procedure that provides a measurement to ensure that your critical limit that all fish were chilled to 50?F within 6 hours of death and brought to 40?F within an additional 18 hours was accomplished. Obtaining truthful harvest vessel records that include appropriate on-board information and measurements is warranted to ascertain if this critical limit was met.
You must implement the record keeping system listed in your HACCP plan to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the receiving critical control point to control histamine formation as listed in your HACCP plan for histamine-producing fish. Specifically, in addition to the deficiency in the monitoring procedure for internal temperature measurements listed above, there was no record of temperature measurements taken on bluefish received from the F/V [redacted] 1/13/01 or from the F/V [redacted] 1/6/01.
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.
Please respond in writing within three (3) weeks from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You may wish to include in your response documentation such as a revised HACCP plan, copies of monitoring records that reflect implementation of revised monitoring procedures, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when the corrections will be completed.
This letter may not list all deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations and the Current Good Manufacturing Practice regulations (21 CFR 110).You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug and Cosmetic Act and all applicable regulations.
Your response to this letter should be directed to the U.S. Food and Drug Administration, Attention: Anthony M. Criscuolo Jr., Acting Compliance Officer at the address and telephone number listed above.Sincerely,
Douglas I. Ellsworth
New Jersey District