Inspections, Compliance, Enforcement, and Criminal Investigations

Rushing Waters Fisheries, LLC 11/17/17



Black HHS-Blue FDA Logo



Office of Human and Animal Foods - West Division 1
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
(612) 334-4100 


November 17, 2017
Via UPS Overnight Delivery                                                       
Refer to CMS 535009
Peter J. Fritsch
Rushing Waters Fisheries, LLC
N301 County Road H
Palmyra, Wisconsin  53156-9655
Dear Mr. Fritsch:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility located at N301 County Road H, Palmyra, Wisconsin, 53156-9655, on seven days between April 3 and May 1, 2017. During our inspection FDA collected environmental samples (i.e., swabs) from various areas in your processing facility, including areas that are in close proximity to food and food-contact surfaces. FDA laboratory analyses of the environmental swabs identified the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Based on this analysis we have determined that your seafood products are 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), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.  Additionally, FDA found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123) and the Current Good Manufacturing Practice (CGMP) regulation for foods, 21 CFR 110.[1] 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 Act. Failure to manufacture foods in accordance with the CGMP requirements of 21 CFR 110 also renders your firm’s products adulterated within the meaning of section 402(a)(4) of the Act.  You may find the Act and FDA's regulations through links on FDA’s home page at
This inspection resulted in FDA’s issuance of a FDA Form-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your firm’s response dated June 1, 2017, to the FDA-483, which included a description of corrective actions taken by your firm. The adequacy of these corrective actions and your firm’s implementation of them will be assessed during your next inspection.
Your firm’s significant violations are described below.
Presence of L. monocytogenes
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans or equipment.  Without proper controls it can proliferate in food processing facilities where it may contaminate food.  Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to apply controls or take corrective actions as necessary to eradicate the organism.  Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.
FDA laboratory analysis of the environmental samples INV973463 and INV973464 collected on April 3-4, 2017, confirmed that 14 environmental swabs were positive for L. monocytogenes. One swab isolated L. monocytogenes from (b)(4). Another swab isolated L. monocytogenes from (b)(4)
Specifically, the 14 positive environmental swabs were collected from the following locations:
Sample INV 973463
  • (b)(4)
  • (b)(4)
  • (b)(4)
  • (b)(4)
  • (b)(4)
  • (b)(4) 
Sample INV 973464
  • (b)(4)
  • (b)(4)
  • (b)(4)
  • (b)(4)
  • (b)(4)
  • (b)(4)
  • (b)(4)
  • (b)(4) 
Whole Genome Sequencing (WGS) analysis was conducted on the six L. monocytogenes isolates obtained from an FDA environmental sample collected on April 3, 2017, and eight L. monocytogenes isolates obtained from an FDA environmental sample collected on April 4, 2017. WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness.  WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome. At this time, the comparison of WGS data from the 14 isolates found at your facility show that there is one strain of L. monocytogenes present in your facility.  The 14 isolates cluster together and are not a match to any other isolates in the database (e.g., clinical or other food/environmental isolates).
The presence of L. monocytogenes in samples collected from your firm demonstrates that your sanitation procedures were inadequate to protect against contamination with this pathogenic organism.  Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism.
We acknowledge your June 1, 2017, response outlining the corrective actions you have taken in response to the L. monocytogenes environmental sample findings.  We acknowledge that your firm’s response indicates that you have re-cleaned and have begun taking environmental swabs of the processing area.  However, your response cannot be evaluated for whether you have taken steps to eliminate L. monocytogenes from your processing environment or effectively prevent it from contaminating finished products you may manufacture in the future.  We recommend that you review FDA’s draft guidance for industry entitled “Control of Listeria monocytogenes in Ready-To-Eat Foods” for assistance in developing your Listeria control plan.  The draft guidance can be found at
Seafood HACCP Violation
You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with CGMP requirements in 21 CFR 110 to comply with 21 CFR 123.11(b). However, your firm did not monitor the condition and cleanliness of food-contact surfaces, the prevention of cross-contamination, and the protection of food, food packaging material and food-contact surfaces from condensate with sufficient frequency to ensure compliance with the CGMP requirements as evidenced by observations including the following:
(1) In the Smoke/Finished Product Cooler, water was observed dripping directly onto containers of (b)(4) sour cream (Best By 4/27/17) from melting ice on the bottom of the condenser unit located along the east wall. The sour cream is used as an ingredient in your RTE smoked salmon and trout spreads. After moving the pallet away from the dripping condensate, a pool formed on the floor. (b)(4).
(2) A blue apron worn by a production employee in the main processing room was hanging near a tiered rolling rack with thawing fish. The dirty apron was in direct contact with the fish. (b)(4).
(3) An employee placed a net, used to transfer raw fish from a large tote to the eviscerator table, directly onto the floor and proceeded to clean the net with a high pressure hose while raw fish were thawing on racks nearby.  (b)(4). Another employee was observed spraying down lids used for brining barrels also near thawing fish.  The use of a high pressure washer can cause cross-contamination by creating aerosols and overspray.
(4) A cracked clear bin and several cutting boards were observed to have deep gouges on their cutting surfaces. The conditions of these direct food-contact surfaces are not smooth and cleanable which could allow for areas of pathogen growth.
Your response indicates that you have removed the ice, cleaned and sanitized the coil of the condenser unit, installed additional foot-foamers, redirected foot traffic, and re-trained your staff. We will ascertain the adequacy of your corrective action during our next inspection.
CGMP Violations
You must meet the CGMP requirements in 21 CFR 110.  However, your firm did not comply with the CGMP requirements as required by 21 CFR 110.35(a).  Specifically, the floor in the oven/smoker room was damaged to the extent that pieces of it were coming off during cleaning. Additionally, the floor between the raw cooler and the freezer where you enter the plant from the warehouse appeared pitted.
Your firm’s verbal response given during the close-out meeting on May 1, 2017, indicates that you will be repairing/re-placing the floor at an unspecified time in 2017. We will ascertain the adequacy of your corrective action during our next inspection.
This letter is not intended to be an all-inclusive list of the violations that exist in connection with your products.  It is your responsibility to ensure that your products are in compliance with the Act and all applicable laws, including CGMP requirements in 21 CFR 110.
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in regulatory action without further notice including, without limitation, seizure and injunction.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct violations, including an explanation of how your firm plans to prevent the recurrence of the violations described above or the occurrence of similar violations. More specifically, your response should include documentation of the corrections and/or corrective actions (which should address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Please include copies of any available documentation demonstrating corrections have been made.
Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs.  A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved.  Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the reinspection fees, 21 USC 379j-31(a)(2)(B).  For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your response to Compliance Officer Dianna C. Sonnenburg at the address above. If you have questions regarding any issues in this letter, please contact Ms. Sonnenburg at (612) 758-7125.
Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Foods Operations

[1] Part 110 was modernized and codified in subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR 117) (CGMP and PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See
FSMA/ucm334115.htm#Compliance_Dates for CGMP and PC rule compliance dates.

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