WARNING LETTER
Voehlganic Farm LLC
MARCS-CMS 698230 —
May 28, 2025
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Charles E. Voehl
Recipient Title
Owner
Voehlganic Farm LLC
S2451 Bethesda Rd.
Westby
,
WI
54667
United States
Issuing Office:
Human Foods Program
United States
May 28, 2025
WARNING LETTER
CMS #698230
Dear Mr. Voehl:
On August 28 and 30, 2024, the United States Food and Drug Administration (FDA) conducted an inspection of your shell egg farm located at S2451 Bethesda Rd., Westby, Wisconsin 54667. During our inspection of your farm, FDA investigators observed serious violations of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (the Shell Egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR Part 118). At the conclusion of the inspection, FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations, listing deviations found at your farm.
Based on FDA’s inspectional findings, we have determined that the shell eggs produced on your farm do not comply with the provisions of 21 CFR Part 118. Failure to comply with the provisions of 21 CFR Part 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act (the PHS Act), 42 U.S.C. § 264(a). In addition, these violations render your shell eggs adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 whereby they may have been rendered injurious to health. You may find the FD&C Act, the PHS Act and the Shell Egg regulation through links on FDA’s home page at www.fda.gov.
We received your written response to the FDA-483, September 2, 2024, via email, which described corrective actions taken or planned by your farm. Your written response contained some elements of a Salmonella Enteritidis Prevention Plan (SE Prevention Plan); however, based on our review of the inspectional findings and your response, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your farm.
Your significant violations are as follows:
Shell Egg Regulation (21 CFR Part 118)
1. You did not have and implement a written SE Prevention Plan that includes, at a minimum, the SE prevention measures required by 21 CFR 118.4. At the initiation of the August 2024 inspection, your
(b)(4)
poultry houses contained approximately
(b)(4)
layers and you distributed shell eggs to the table market. You indicated during the inspection that you did not have a written SE Prevention Plan. You are required to have an SE Prevention Plan that includes, at a minimum, the SE prevention measures outlined in 21 CFR 118.4 (a) – (e), which include:
a.
Pullets
A written SE Prevention Plan must include, among other things, the required SE prevention measures relating to pullets. Under 21 CFR 118.4(a), these measures include procuring pullets that are SE monitored or raising pullets under SE monitored conditions. Under 21 CFR 118.4(a)(1), “SE monitored” means (among other things) that chicks are procured from SE-monitored breeder flocks that meet the National Poultry Improvement Plan's standards for “U.S. S. Enteritidis Clean” status (9 CFR 145.23(d)) or equivalent standard. Under 21 CFR 118.4(a)(2), “SE monitored” also means that the pullet environment is tested for SE when pullets are 14-16 weeks of age.
As discussed above, you indicated during the inspection that you did not have a written SE Prevention Plan. We acknowledge that during the inspection you provided documentation indicating that you had obtained your flocks from pullet growers, that the chicks were “SE Clean”, and that the pullet environment was tested for SE at 14-16 weeks. However, as a producer, you are required to have and implement a written SE Prevention Plan that addresses all the elements of procuring SE Monitored pullets. Your written response included an SE Prevention Plan with a section on environmental sampling. The beginning of that section states, “Chicks are procured from breeder flocks that meet NPIP standards. The pullet environment is tested for SE between 14 and 16 weeks of age”. This procedure does not specify that the SE-monitored breeder flocks must meet the National Poultry Improvement Plan's standards for “U.S. S. Enteritidis Clean” status (9 CFR 145.23(d)) or equivalent standard, as required by 21 CFR 118.4(a)(1).
b.
Biosecurity
A written SE Prevention Plan must include, among other things, the required SE prevention measures relating to biosecurity, as stated in 21 CFR 118.4(b). These biosecurity measures must include, at a minimum:
 Limiting visitors on the farm and in the poultry houses (21 CFR 118.4(b)(1));
 Maintaining practices that will protect against cross contamination when equipment is moved among poultry houses (21 CFR 118.4(b)(2));
 Maintaining practices that will protect against cross contamination when persons move between poultry houses (21 CFR 118.4(b)(3));
 Preventing stray poultry, wild birds, cats, and other animals from entering poultry houses (21 CFR 118.4(b)(4)); and
 Not allowing employees to keep birds at home (21 CFR 118.4(b)(5)).
As discussed above, you indicated during the inspection that you did not have a written SE Prevention Plan. We acknowledge that your written response included an SE Prevention Plan with a biosecurity procedure to address employees not keeping birds at home, elements of a visitor policy, and cleaning and disinfection of tools and equipment. However, this section of your SE Prevention Plan lacks supporting detail to further assess how you will implement these practices. Further, this biosecurity section is inadequate in that it does not address how to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses. In addition, while the visitor policy does include practices to protect against cross contamination when visitors enter the facility, nothing in this section of your SE Prevention Plan addresses practices to protect against cross contamination when other persons (e.g., employees) move between poultry houses.
c.
Rodents, Flies, and Other Pest Control
A written SE Prevention Plan must include, among other things, the required rodent, fly, and other pest control measures as stated in 21 CFR 118.4(c). As discussed above, you indicated during the inspection that you did not have a written SE Prevention Plan. While you provided some details regarding your pest control practices, these details indicated that you were not monitoring for the presence of rodents and flies by appropriate monitoring methods, as required by 21 CFR 118.4(c)(1) and 21 CFR 118.4(c)(2). Specifically, for rodents, you did not identify a threshold for acceptable or unacceptable activity, nor did you identify corrective actions to take if unacceptable activity was observed. You stated you perform your own pest control program using bait stations and place
(b)(4)
stations within each of the
(b)(4)
poultry houses. The inspection of the bait stations was documented weekly on the production record with a check mark, but no other information was recorded (including amount of bait consumed or if bait was replaced). For flies, you did not routinely monitor fly activity, did not identify a threshold for acceptable and unacceptable fly activity, and did not identify corrective actions to take if unacceptable activity was observed.
We acknowledge that your written response included an SE Prevention Plan with procedures for rodent control and fly control. However, your rodent control protocol does not provide enough detail for us to assess whether or not it is adequate. For example,
(b)(4)
, but it is unclear how you determined this threshold. Without understanding how the threshold was established, we cannot evaluate whether
(b)(4)
rodents is an acceptable threshold for your poultry houses.
d.
Cleaning and Disinfection
A written SE Prevention Plan must include, among other things, cleaning and disinfection procedures for the poultry house as stated in 21 CFR 118.4(d). You must clean and disinfect the poultry house according to these procedures before new laying hens are added to the house, if you have had an environmental test or an egg test that was positive for SE at any point during the life of a flock that was housed in the poultry house prior to depopulation. As discussed above, you indicated during the inspection that you did not have a written SE Prevention Plan. Moreover, the SE Prevention Plan that was included with your written response did not contain a cleaning and disinfection procedure as required by 21 CFR 118.4(d).
e.
Refrigeration
A written SE Prevention Plan must include, among other things, the SE prevention measures related to refrigeration that are required by 21 CFR 118.4(e). As discussed above, you indicated during the inspection that you did not have a written SE Prevention Plan.
We acknowledge that your written response included an SE Prevention Plan with procedures for refrigeration of the shell eggs. We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.
2. You did not conduct environmental testing for SE in your poultry houses when laying hens were 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, at the time of the inspection, your flocks were approximately
(b)(4)
weeks and
(b)(4)
weeks of age and you stated that you had not conducted any environmental testing during the required 40–45-week timeframe for approximately
(b)(4)
years.
To date, you have not provided any documentation of testing and therefore we are unable to determine the SE status of your houses. Please note that the environmental sampling required by 21 CFR 118.5(a) must be done using a sampling plan that is appropriate to the poultry house layout, as required by 21 CFR 118.7(a).
We acknowledge that your written response included an SE Prevention Plan with an environmental sampling procedure, indicating that the barn would be swabbed when the hens are between 40-45 weeks of age, and that
(b)(4)
swabs would be collected from each house. However, you did not provide sufficient detail to ensure that your sampling plan is appropriate to the poultry house layout. For example, you did not provide a diagram or description of the location from which the swabs are taken, which could be used to establish that the
(b)(4)
swabs will cover an appropriately representative portion of the poultry house.
In addition, you stated during the inspection that hens from both houses are able to commingle when they are utilizing the outdoor space. You did not indicate a process for ensuring that hens return to their original houses, and we are unaware of a process that could ensure this. It therefore seems possible that each of your poultry houses has hens from both flocks, in which case each house would need to undergo environmental testing when either flock reaches 40-45 weeks of age. More generally, you should consider the biosecurity implications of this commingling, which could result in cross-contamination between the two houses. Under 21 CFR 118.4(b), you must take steps to ensure that there is no introduction or transfer of SE into or among poultry houses.
This letter is not intended to be an all-inclusive statement of the violations that may exist at your farm or in connection with your shell eggs. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your shell egg production practices are conducted in compliance with federal law, including the FD&C Act, the PHS Act, and the Shell Egg regulation.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).
Additional Comment
Records are an important component to ensure your compliance with FDA’s Shell Egg regulation. 21 CFR 118.10 describes the records required for your SE Prevention Plan and other general recordkeeping requirements. We encourage you to review these requirements when working to develop and implement your SE Prevention Plan and environmental testing procedures.
Please note that resources are available on our website at www.fda.gov/eggs that address various aspects of shell egg regulation, including the topics addressed in this letter. For example, the December 2011 Guidance for Industry “
Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation
” addresses topics such as rodent monitoring; the August 2022 Guidance for Industry “
Questions and Answers Regarding the Final Rule on Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House)
” provides information specific to operations where layers have access to areas that are outside the poultry house; and the July 2015 Guidance for Industry “
Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation
” provides answers to common questions about the Shell Egg regulation.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that you have complied with pertinent laws and regulations, include your reasoning and any supporting information for our consideration.
Your written response should be sent electronically to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Lisa Thursam, Compliance Officer, at Lisa.Thursam@fda.hhs.gov. Refer to Unique Identification Number, CMS 698230, when replying. If you have questions regarding this letter, please contact Lisa Thursam, Compliance Officer, at Lisa.Thursam@fda.hhs.gov.
Sincerely,
/S/
Maria S. Knirk, JD MBA
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Food and Drug Administration
Content current as of:
07/08/2025
Regulated Product(s)
Food & Beverages