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February 9, 2024

WARNING LETTER
CMS 668611

Dear Mr. Zoet:

The U.S. Food and Drug Administration (FDA) and the Michigan Department of Agriculture and Rural Development (MDARD) inspected your shell egg farm located at 4847 140th Ave. Holland, MI 49423 from August 15, 2023, through August 23, 2023. The inspection revealed serious violations of Title 21, Code of Federal Regulations, Part 118 (21 CFR Part 118), Production, Storage and Transportation of Shell Eggs. Failure to comply with the provisions of 21 CFR Part 118 causes your 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 under 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 whereby they may have been rendered injurious to health. You can find the Act, PHS Act, and FDA regulations through links on FDA’s home page at www.fda.gov.

At the conclusion of the inspection, the FDA investigator issued an FDA Form 483 (FDA-483), Inspectional Observations. You provided a response to the inspection on September 6, 2023, describing taken or planned corrective actions. After reviewing the inspectional findings and your response, we are issuing this letter to advise you of FDA’s concerns, provide detailed information describing the findings at your farm, and address your response below.

Your significant violations are as follows:

1. You did not have and implement a written Salmonella Enteritidis (SE) Prevention Plan that includes, at minimum, the SE prevention measures, as required by 21 CFR 118.4. At the initiation of the current inspection, you indicated that you only have certain components of an SE Prevention Plan, but did not have a formal plan. Specifically:

a. You did not have written procedures that procured pullets are SE-monitored or pullets are raised under SE-monitored conditions, as required by 21 CFR 118.4(a)(1), and that the pullet environment will be tested for SE when pullets are 14-16 weeks of age, as required by 21 CFR 118.4(a)(2).

In your response, you provided an SE Prevention Plan describing the procurement of chicks from U.S. SE clean flocks and indicating that the pullet environment will be tested at 14-16 weeks; however, your plan indicates that your response to a positive SE test on the pullet farm would be to not accept the flock until a negative test is received. This is inadequate; if the pullet environment tests positive for SE, a producer must begin egg testing within two weeks of the start of egg production or divert eggs to treatment for the life of the flock, as required by 21 CFR 118.6(a)(1). We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

b. You did not implement your rodent monitoring procedure, as required by 21 CFR 118.4(c)(1). Specifically, your “Zoet Poultry Biosecurity Procedure Standard Operating Procedure 4”, stated that your farm monitors rodent activity using “effective monitoring devices which may include but are not limited to live traps.” However, during the inspection, you stated that the only interior monitoring devices used were rodent bait stations within houses (b)(4). Further, our investigator did not observe methods for monitoring rodent activity inside houses (b)(4). Additionally, the monitoring record you provided to the investigator to indicate that “rodent bait [was] monitored and replaced” on a (b)(4) basis was not specific to the house where rodent bait was monitored and replaced. Further, you did not identify a threshold to monitor bait consumption to determine acceptable or unacceptable rodent activity.

In your response, you included your updated SE Prevention Plan describing your current methods to monitor rodent activity and provided records for rodent monitoring in houses (b)(4). However, your updated plan does not describe your intervention plan, does not include a threshold for taking corrective action, and does not indicate the type of corrective actions that would be taken to adequately address unacceptable rodent activity. Additionally, the record provided for house (b)(4) did not indicate that monitoring was completed for the week of September 6, 2023. Further, although it appears that you have added traps to these houses, it is unclear what monitoring method you are using and if these monitoring devices are present in all houses on your farm. We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

c. You did not implement your fly monitoring procedure, as required by 21 CFR 118.4 (c)(2). Your “Zoet Poultry Biosecurity Procedure Standard Operating Procedure 4”, stated that your farm monitors fly activity by using “effective monitoring devices which include, but are not limited to spot cards set up around the coop.” However, during the inspection, the investigator did not observe spot cards or other methods for monitoring fly activity in houses (b)(4). Additionally, your monitoring record provided to the investigator indicated that “fly bait [was] monitored and replaced” on a (b)(4) basis but was not specific to the house where fly bait was monitored and replaced. Further, you did not identify a threshold to determine acceptable or unacceptable fly activity.

In your response, you included your updated SE Prevention Plan describing your current methods to monitor fly activity and provided records for fly monitoring in houses (b)(4). However, although your updated SE Prevention Plan and the information in your records indicate that you are currently monitoring for fly activity using “effective monitoring devices which include, but are not limited to, the moving tape method”, it is unclear which method you used in the records provided. Additionally, the record you provided for house (b)(4) did not indicate that monitoring was completed for the week of September 6, 2023. We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

2. You failed to conduct environmental testing for SE, using approved methods, in a poultry house when any group of laying hens constituting the flock were 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, you failed to conduct environmental testing for SE in the following poultry houses when any group of laying hens constituting the flock were 40 to 45 weeks of age:

• House (b)(4) consisting of (b)(4) birds with the hatch date 09/05/2022. The laying hens were approximately 49 weeks old at the time of the inspection.
• House (b)(4) consisting of (b)(4) birds with the hatch date 06/03/2022. The laying hens were approximately 62 weeks old at the time of the inspection.
• House (b)(4) consisting of (b)(4) birds with the hatch date 04/01/2022. The laying hens were approximately 71 weeks old at the time of the inspection.
• House (b)(4) consisting of (b)(4) birds with the hatch dates 09/08/2022 and 09/09/2022. The laying hens were approximately 49 weeks old at the time of the inspection.
• House (b)(4) consisting of (b)(4) birds with the hatch dates 08/15/2022 and 08/16/2022. The laying hens were approximately 51 weeks old at the time of the inspection.

In your response, you provided results from environmental samples collected from houses (b)(4) after the required time period for testing indicating that the houses were found negative for SE. You also provided your revised SE Prevention Plan which contains procedures for collecting environmental samples within your poultry houses. We will verify the implementation and adequacy of your corrective actions, including testing at the appropriate flock age intervals, during the next FDA inspection.

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. It is your responsibility to investigate and determine the cause of the violations identified above and for preventing their reoccurrence 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 FDA’s egg safety rule.

In addition to the above violations, we offer the following comment:

Your updated SE Prevention Plan indicates that you place environmental samples in (b)(4) with “(b)(4)”. FDA’s egg safety rule requires producers to follow “Environmental Sampling and Detection of Salmonella in Poultry Houses” April 2008 or an equivalent method in accuracy, precision, and sensitivity in detecting SE. Transporting samples in (b)(4) could potentially lead to inaccurate test results, and we encourage you to review your procedures to ensure that your collection and testing methodology is equivalent to FDA’s egg safety rule requirements.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If corrective actions cannot be completed within fifteen (15) working days of receipt of this letter, please state the reason for the delay and the timeframe within which the corrections will be completed. If you believe that you have complied with pertinent laws and regulations, include your reasoning and any supporting documentation for our consideration.

Please send your written response to Daniel Arrecis, Compliance Officer, at ORAHAFEAST6FirmResponses@fda.hhs.gov. Alternatively, you may mail your response to Daniel Arrecis 550 W. Jackson Suite 800 Chicago, IL 60661. If you should have any questions regarding this letter, please contact Daniel Arrecis at (312) 596-4263.

Sincerely,
/S/

William R. Weissinger, MS
Program Division Director
Office of Human and Animal Foods Operations East
Division 6