| Public Health Service Food and Drug Administration |
| New England District One Montvale Avenue Stoneham, Massachusetts 02180 Phone: (781) 587-7500 FAX: (781) 587-7556 |
Department of Health and Human Services
WARNING LETTER
NWE-08-11W
VIA UPS
February 4, 2011
Philip E. Wilbur, President
KJPL Restaurants Inc.
dba Hurricanes Soup & Chowder Co.
682 US RT 202
Greene, Maine 04236
Dear Mr. Wilbur:
We inspected your seafood processing establishment, located at Greene, Maine on 10/27/2010-11/12/2010. 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 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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 Lobster Bisque is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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:
You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.
However, your firm's HACCP plan for “Soup with Fish & Shellfish & Mollusks,” does not list the food safety hazard of Clostridium botulinum. Clostridium botulinum growth and toxin formation is a reasonably likely hazard during the (b)(4). In addition, the packaging materials for your finished soup products create a potential for Clostridium botulinum growth and toxin formation.
We suggest the following:
a. Establishing an adequate cook process, such as that recommended in the Guide, to achieve a 6D process to control Clostridium botulinum growth and toxin formation. (i.e., refer to Table #A-4 in the Guide). As currently listed, the critical limits at the heat/cook critical control point in your plan, (b)(4). In addition, when relying on cook times/temperatures, FDA also recommends use of equipment capable of continuously monitoring and recording the cook cycle for the entire duration of the cook step, as well as the use of a continuous filling system with a hot fill to prevent post-process contamination. As alternatives to cooking and utilizing a continuous hot filling system, your firm may consider the use of time/temperature indicators (TTIs) on the finished product package; or distributing the finished product frozen; or altering the formulation of the finished product to include a secondary barrier to Clostridium botulinum
b. Additional controls at the chilling critical control point to control post-process contamination. Your HACCP plan should specify the target temperatures and times. The recommendation is to reduce the temperature to 70°F within 2 hours and then to achieve 40°F or below within an additional 4 hours.
c. An adequate critical control point for finished product storage for the refrigerated products (i.e., those with label instructions that state “keep refrigerated”). We suggest a method of continuously monitoring and recording storage temperatures, with a daily check of the record and a daily check of the equipment.
Further, your firm’s HACCP plan for “Soup with Fish & Shellfish & Mollusks,” does not list the food safety hazard of Listeria monocytogenes. Listeria monocytogenes is a reasonably likely hazard during receiving and cooler storage of fresh lobster claw/knuckle.
We received your undated response to the FDA 483 issued to your firm on November 12, 2010 and find it inadequate. You state your specialists have advised you that in order to control the hazard of Clostridium botulinum, you should conduct (b)(4). However, as noted in the paragraph above, you fail to identify the hazard of Clostridium botulinum in your HACCP plan and your plan does not reference this as a step or process in your manufacturing operation. But as a control strategy, we do not agree (b)(4). Our data and information suggests that the oxygen in the headspace will eventually be used up and the packaging environment will become anaerobic, as a reduced oxygen package.
Further, your response indicates that you will be taking temperatures at the cook step (b)(4). Taking intermittent temperatures does not ensure the temperature goes below the critical limit for an extended time. As noted above, FDA recommends use of equipment capable of continuously monitoring and recording the cook cycle for the entire duration of the cook step.
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 have done, since your August 18, 2010 correspondence, 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: Bruce R. Ota, Compliance Officer at the above address. If you have questions regarding any issues in this letter, please contact Mr. Otaat 781-596-7762.
Sincerely,
/S/
Mutahar S. Shamsi
District Director
New England District
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