| Public Health Service Food and Drug Administration |
Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7210 FAX: (612) 334-4142 |
Department of Health and Human Services
October 14, 2010
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 02
Ronald J. Blum
Owner
Blum’s Spring Lake Fisheries
4887 Lynn Hollow Lane
Potosi, Wisconsin 53820
Dear Mr. Blum:
Investigators from the Food and Drug Administration (FDA) inspected your seafood processing facility located at 4887 Lynn Hollow Lane, Potosi, Wisconsin, onApril 26 and May 26, 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, the Current Good Manufacturing Practice regulation for foods, and 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 fresh and smoked fish are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Additionally, we have found violations of 21 CFR 100, Food Labeling, thereby causing your smoked fish to be misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2). 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 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 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 HACCP plans for smoked salmon to control the food safety hazards of pathogen growth and toxin formation and pathogen survival through cooking and ready-to-eat raw buffalo fish eggs to control pathogen growth and toxin formation.
- You must conduct a hazard analysis 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 critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can, as a result, be prevented, eliminated, or reduced to acceptable levels.” However, your HACCP plan for smoked fish does not list the critical control points for the brine step of the process and for refrigerated storage of finished products to control pathogen growth and potential toxin formation.
During the inspection our investigator did observe that your firm records cooler temperatures [(b)(4)] per day while fish products are in the cooler. Please be advised that FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated storage. Intermittent temperature checks as a monitoring procedure during refrigerated storage are not adequate to ensure that products are not exposed to elevated temperatures for extended time periods due to fluctuations occurring between those checks. FDA also recommends a daily check of the recorded temperatures to ensure that proper temperatures have been maintained, and a daily check of the monitoring equipment itself to ensure that it is operating properly.
- 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 procedures, “Temperature Control Recording Chart” at [ (b)(4) ] CCP, “[ (b)(4) ].” Our investigator compared the readings on your temperature records with a calibrated thermometer in a jar of hot water. The calibrated thermometer registered 169ËšF, the digital read-out of the temperature recorder read 165ËšF, but the chart recorder was recording a temperature close to 210ËšF.
- You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However,
- Your firm did not monitor processing conditions with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b) conditions and cleanliness of food contact surfaces as evidenced by a build-up of residue on your smoker racks. During our investigation you told our investigator that the smoker racks are not cleaned between batches.
- Your firm did not monitor processing conditions with sufficient frequency to ensure compliance with 21 CFR 110.20(a)(1) and 21 CFR 110(b)(7):
i. The grounds of the facility are scattered with unused equipment that create a harborage for rodents and other pests.
ii. The door on the processing building has gaps that allow ingress for pests.
iii. There is apparent nesting material and droppings on the ground in the smokehouse structure.
- You must maintain sanitation control records that, at a minimum, document monitoring and prescribed corrections, to comply with 21 CFR 123.11(c). However, your sanitation monitoring records only state that you cleaned and sanitized your processing equipment and surfaces after processing; no other information is recorded for the other seven required sanitation controls. A model Daily Sanitation Control Record and a model Written Sanitation Standard Operating Procedure were provided to you during the inspection.
- Your Barbecued Smoked Carp and Smoked Catfish are misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), in that they are fabricated from two or more ingredients, but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4 as follows:
• Your Barbecued Smoked Carp and Smoked Catfish product labels both declare fish as an ingredient; however, you fail to list the specific species of fish used for each product in the ingredient statement.
The requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food, 21 CFR 101.4(b)(2).
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
We acknowledge receipt of your written response dated June 14, 2010, in which you committed to closing the gap in the door to the processing room. In your response to us, please include documentation that the gaps have been closed. Please ensure you are familiar with the regulations and requirements as stated above and that you are in compliance with the law. You should respond in writing within 15 working days from the 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.
In addition to the above observations, we note that your Barbecued Smoked Carp and Smoked Catfish products do not bear a net quantity of contents statement. We are aware that your products are packaged in bulk varying in size and sold to retail stores who then sell them to consumers. If the products are intended to be weighed and marked with the net weight at the point of retail sale, your labeling must meet the requirements set forth in 21 CFR 101.100(h).
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), the Current Good Manufacturing Practice regulation (21 CFR 110), and the food labeling regulation (21 CFR 100). 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: Demetria Lueneburg, Compliance Officer, 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota 55401. If you have questions regarding any issues in this letter, please contact Ms. Lueneburg at (612)758-7210.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
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