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  1. Warning Letters

WARNING LETTER

North Creek Farm MARCS-CMS 709020 —

Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Allen H. Hurst
Recipient Title
Owner
North Creek Farm

1914 State Route 169
Little Falls, NY 13365
United States

Issuing Office:
Human Foods Program

United States

WARNING LETTER

September 24, 2025

CMS #709020

Dear Mr. Hurst:

On February 24, 2025, through April 14, 2025, the United States Food and Drug Administration (FDA) conducted an inspection of your shell egg farm and egg processing facility, where your shell eggs are washed, graded, and packed, located at 1914 State Route 169, Little Falls, NY 13365. During the 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 the 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 (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.

To date, we have not received a written response to the FDA-483 and are therefore unable to evaluate any corrective actions you might have taken. Based on our review of the inspectional findings, 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 Salmonella Enteritidis (SE) Prevention Plan (SE Prevention Plan) that includes, at a minimum, the SE prevention measures required by 21 CFR 118.4. As a shell egg producer with 3,000 or more laying hens at your farm who does not sell all of your eggs directly to consumers and who produces shell eggs for the table market, you are required to comply with the Shell Egg Regulation. As part of that regulation, you are required to have an SE Prevention Plan that includes, at 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 an 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. In addition to not having an SE Prevention Plan to address pullet procurement, you were not able to provide any documentation to indicate that your pullets were procured from SE-monitored breeder flocks or were raised under SE monitored conditions. Furthermore, you were not able to provide records indicating the pullet environment had been tested at 14-16 weeks of age. You are required to have and implement a written SE Prevention Plan that addresses all the elements of procuring SE Monitored pullets or raising pullets under SE monitored conditions.

b. Biosecurity
A written SE Prevention Plan must include, among other things, the required SE prevention measures relating to biosecurity, as required by 21 CFR 118.4(b). That provision requires you to take steps to ensure that there is no introduction or transfer of SE into or among poultry houses. 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. During the inspection, you indicated that you have implemented a biosecurity measure to restrict access to your (b)(4) house with a posted sign on the door. However, you must also have a written SE Prevention Plan that implements all the biosecurity measures referenced above. We acknowledge (b)(4) on your farm; however, you must still take steps to prevent the introduction of SE into that poultry house.

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 required by 21 CFR 118.4(c).

As discussed above, you indicated during the inspection that you did not have a written SE Prevention Plan. In addition to not having an SE prevention Plan, 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). For example, you stated (b)(4). This is inadequate, as you must monitor for rodent activity within the poultry house. Furthermore, you did not monitor for fly activity within the poultry house.

Additionally, you did not have a written SE Prevention Plan to address removal of debris within a poultry house and vegetation and debris outside a poultry house that may provide harborage for pests, as required by 21 CFR 118.4(c)(3). During the inspection, investigators observed the following conditions:
• On February 27, 2025, March 27, 2025, and April 14, 2025, broken and cracked eggs were observed in a pile outside approximately (b)(4) feet from the (b)(4) entry door to your (b)(4) house. You stated you throw the eggs out for other birds or animals to eat.
• Water was leaking from the ceiling onto the (b)(4) elevated slat area containing the feeder lines and nesting boxes.
• Condensation was built up on the ceiling and pooled water was noted in the litter/scratch area throughout your laying house.

We are concerned that the condition of your poultry house and (b)(4) areas could serve as an attractant or harborage for pests, rodents, and other animals that are known vectors of pathogens. Manure should be kept as dry as possible to make it less attractive to flies (and other insects) and disposal of eggs outside your poultry house may be a food source for insects, rodents, and other pests.

d. Cleaning and Disinfection
A written SE Prevention Plan must include, among other things, cleaning and disinfection procedures for the poultry house, as required by 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.

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. In addition, you stated (b)(4). You must ensure eggs are held and, if applicable, transported at or below 45°F ambient temperature beginning 36 hours after time of lay, and have written procedures that address these refrigeration requirements, as required by 21 CFR 118.4(e).

To date, we have not received a copy of your SE Prevention Plan or a response outlining corrective actions, and thus, we are unable to evaluate your preventive measures or any corrective actions you might have taken.

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 flock was approximately (b)(4) weeks of age and you stated (b)(4) during the required 40–45-week timeframe. Testing is important to know the SE status of your production systems. Production environments positive for SE carry a higher probability of producing SE contaminated eggs. Additionally, testing is an indicator of how well SE is controlled in a production system.

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 Comments

In addition to the items indicated above, you must have an SE plan administrator, as required by 21 CFR 118.9. The SE plan administrator is responsible for ensuring compliance with your farm’s SE prevention plan, including developing and implementing an SE prevention plan and reassessing and modifying it as necessary to ensure the requirements in 21 CFR 118.4 are met. The SE plan administrator does not have to be on-site; however, you can act as your own SE plan administrator.

You must also maintain records documenting compliance with the SE prevention measures as required by 21 CFR 118.10. This includes keeping records documenting compliance with SE monitored pullet requirements, biosecurity, rodent and pest control, cleaning and disinfection procedures, and refrigeration requirements. All records must have the name and location of your farm, the date and time of the activity, and the signature or initials of the person performing the activity or creating the record.

Investigators provided hard copies of resources that address various aspects of the Shell Egg Regulation, including the topics addressed in this letter, at the initiation of the inspection. Please note that resources are also available on our website at www.fda.gov/eggs. 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 “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. For additional hard copies, please reach out to Lisa Thursam, Compliance Officer, at the address provided below.

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.

Please send your reply via email to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Lisa Thursam, Compliance Officer, at Lisa.Thursam@fda.hhs.gov or by hardcopy to Food and Drug Administration, Attention: Lisa Thursam, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Lisa Thursam, Compliance Officer, via email at Lisa.Thursam@fda.hhs.gov. Please include CMS reference #709020 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Thomas Kuntz
Acting Deputy Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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