Inspections, Compliance, Enforcement, and Criminal Investigations
Neptune Smoked Fish Company LLC 17-Oct-05
Department of Health and Human Services
Public Health Service
Minneapolis District Office
October 17, 2005
RETURN RECEIPT REQUESTED
Refer to MIN 06-07
Neptune Smoked Fish Company LLC
30722 Geneva Road
Salem, WI 53169-9535
Dear Mr. Roberts:
We inspected your seafood processing facility located at 30722 Geneva Road, Salem, Wisconsin, on September 21 and 25, 2005. 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 and 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 Hot and Cold Smoked and Dried 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 most significant violations were as follows:
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 Hot Smoked Fish lists a critical limit, [redacted]" at the cooling critical control point that is not adequate to control Clostridium. botulinum growth. Specifically, this critical limit does not establish an appropriate permissible timefrarne for the product to attain a temperature of 40 degrees Fahrenheit or less.
However, your firm's HACCP plan for Dried Fish lists a critical limit, [redacted] " at the drying critical control point that is not adequate to control Staphylococcus aureus growth. Specifically, this critical limit does not establish a maximum timeframe for the product to be held at up to 70 degrees Fahrenheit.
You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for Hot Smoked, Cold Smoked and Dried Fish lists a monitoring frequency at the storage critical control point that is not adequate to control pathogen growth and toxin formation. Specifically, your HACCP plan requires you to check the temperature of your coolers twice daily "at start & end of production." However, checking the temperature twice daily leaves a gap of several hours between temperature checks and no monitoring of the overnight storage of these products. This is sufficient time for temperatures to fluctuate, rising sufficiently over an unmonitored and extended time period to allow for pathogen growth and toxin formation and also for dropping back down to a safe temperature before the next production check of the temperature. As such, the monitoring frequency currently employed by your firm is inadequate to control pathogen growth and toxin formation. "
You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at any critical control point to control the hazards listed in your HACCP plan for Hot Smoked, Cold Smoked and Dried Fish. Specifically, the operator performing the actions did not document any monitoring activities during production, which occurs during the week; instead, the forms were completed by you on the weekend.
We may take further action if you do not promptly correct these violations. For instarice, 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 123) and the Current Good Manufacturing Practice regulation (21 CFR 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: Tyra S. Wisecup, Compliance Officer. If you have questions regarding any issues in this letter, please contact Ms. Wisecup at (612) 758-7114.
W. Charles Becoat