| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 FAX: (612) 334-4142 |
Department of Health and Human Services
November 7, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 12 - 02
Timothy Winkel
Owner
Silver Moon Springs LLC
W4852 State Highway 64
Elton, Wisconsin 54430-9740
Dear Mr. Winkel:
We inspected your seafood processing facility located at W4852 State Highway 64, Elton, Wisconsin, on July 19 to July 20, 2011. 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 (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 Smoked Salmon, Smoked Trout, and Smoked Salmon Spread 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 on FDA’s home page at www.fda.gov.
Your most significant violations were as follows:
1. 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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for ready-to-eat Smoked Salmon Spread to control the hazards of pathogen growth and undeclared allergens.
2. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a).
a. However, your firm did not take a corrective action to control C. botulinum when your process for (b)(4) deviated from your critical limit at the (b)(4) critical control point. You submitted (b)(4) samples of smoked salmon for (b)(4) on or about February 10, 2011. You were advised that the (b)(4) was significantly lower than your required (b)(4) on or about February 23, 2011. You took no corrective action to ensure that the product did not make it to the market and you did not determine the cause of the failure to ensure that it was not repeated.
b. However, your firm did not take a corrective action to control pathogens and parasites when your process for (b)(4) deviated from your critical limit at the (b)(4) critical control point for smoked trout. The printout of the smoke of June 6, 2011, shows that the process (b)(4). Your review of the smoke process identified the process as “ok.” You took no corrective action to ensure that the product did not make it to the market and you did not determine the cause of the failure to ensure that it was not repeated.
c. Further, you list (b)(4) CCPs (b)(4) in all of your HACCP plans. However, none of the corrective actions require you to determine and to correct the cause of the failures.
3. 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.” Your firm’s HACCP plans for Smoked Salmon and Smoked Trout, regardless of packaging, list a critical limit at the (b)(4) critical control point that is not adequate to control pathogen growth and toxin formation (i.e., associated with the various pathogens listed in the plan). Your plans state a critical limit of (b)(4) but you do not specify the (b)(4) conditions.
4. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8(a). However, your firm did not verify the adequacy of the critical limit of (b)(4) for Smoked Salmon and Smoked Trout at the (b)(4) critical control point to control pathogen growth and toxin formation (i.e., associated with the various pathogens listed in the plan). However, you have never verified that the recipe provides a sufficient (b)(4) and, in fact, have received analytical results showing that the level was not met thereby demonstrating that the recipe is insufficient for the stated purpose.
5. You must implement the record keeping system that you listed in your HACCP plans, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the (b)(4) critical control point for your Smoke Salmon lots 1120-1125 in that you failed to record any (b)(4).
6. 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 frequency of daily record review at the (b)(4) critical control point to control pathogens and parasites listed in your HACCP plan for all smoked salmon and smoked trout, regardless of packaging type.
7. You must implement an affirmative step to ensure that the frozen trout filets that you import from (b)(4) were processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii).
This letter may not list all the violations at your facility. You are responsible for ensuring your firm operates in compliance with the Act and FDA’s implementing regulations. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action, including seizure and/or injunction, without further notice.
Please respond in writing within 15 working days of your receipt of this letter outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence. If you cannot complete all corrections within 15 working days, we expect you to explain the reason for the delay and state when any remaining violations will be corrected.
Please send your reply to the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address on this letterhead. If you have questions regarding the issues in this letter, please contact Ms. Wisecup at (612) 758-7114.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
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