Inspections, Compliance, Enforcement, and Criminal Investigations
New England Smoked Seafood 06-Nov-06
Department of Health and Human Services
Public Health Service
New England District
VIA CERTIFIED MAIL
November 6, 2006
William S. Noel
New England Smoked Seafood
46 Hazel Street
Rutland, VT 05701
Dear Mr. Noel:
We inspected your seafood processing facility, located at 46 Hazel Street, Rutland, VT on August 29, 30 and 31, 2006. We found that you have serious deviations from the Seafood Hazard Analysis and Critical Control Points (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 fishery 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 refrigerated, vacuum packed smoked salmon products 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 this 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 implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure and frequency listed in your HACCP plan for hot smoked, vacuum packed, ready-to-eat salmon at the "Cooler Storage" critical control point. Your monitoring step indicates that you will use a chart reorder to monitor the cooler temperature continuously . We did not observe a chart recorder at your facility.
Instead, we observed that you use a stem thermometer and record the temperature of the cooler once a day.
In addition, your firm did not follow the monitoring procedure of "annual Q.P.S. tests" as listed in your plan at the "Curing/Brining" critical control point.
2. 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, vacuum packed, ready-to-eat salmon lists a monitoring procedure at the "Smoking/Cooking" critical control point that is not adequate to control the hazard of pathogen growth and toxin formation. Your critical limit for the "Smoking/Cooking" critical control point is "minimum internal temp of fish shall be [redacted] for at least [redacted] minutes." However, without a procedure or method capable of continuously monitoring the temperature for the duration of the [redacted] minute cook cycle, there is no assurance that the critical limits listed in your plan have been met.
3. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR Part 123.11(b). However your firm did not monitor exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by the presence of flies in the processing area.
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 any 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: Karen N. Archdeacon, Compliance Officer, at the address noted above. If you have questions regarding any issues in this letter, please contact Ms. Archdeacon at 781-596-7707.
Gail T. Costello
New England District Office