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  5. D.A.Y. Farm - 591433 - 11/20/2019
  1. Warning Letters

WARNING LETTER

D.A.Y. Farm MARCS-CMS 591433 —

Delivery Method:
UPS Overnight Delivery
Product:
Food & Beverages
Egg/Egg Product
Recipient:
Recipient Name
Daniel A. Yoder
Recipient Title
Owner
D.A.Y. Farm

13007 Keller Drive
Saint Charles, MN 55972-4077
United States

Issuing Office:
Office of Human and Animal Foods - West Division 1

United States

Dear Mr. Yoder:

The United States Food and Drug Administration (FDA) inspected your shell egg farm located at 13007 Keller Drive, Saint Charles, Minnesota, on July 15, 16, and 18, 2019.  The inspection revealed 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).  Failure to comply with the provisions of 21 CFR 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 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 Act, the PHS Act, and the Shell Egg regulation through links on FDA’s homepage at www.fda.gov.

We received your written response postmarked July 30, 2019, concerning our investigators’ observations noted on the Form FDA-483 (FDA-483), Inspectional Observations, which was issued on July 18, 2019, at the conclusion of our inspection. We address this response below, in relation to each of the noted violations.

Your significant violations include, but are not limited to, the following:

     1. Your firm failed to have and implement a written Salmonella Enteritidis prevention plan (SE Plan) that includes, at minimum, the SE prevention measures, as required by 21 CFR 118.4.  Specifically, your plan fails to include the following required SE prevention measures: 
       a) Procurement of pullets that are SE-monitored or raised under SE-monitored conditions;
       b) Biosecurity program;
       c) Rodents, flies, & other pest control;
       d) Procedures for cleaning & disinfecting the poultry house; and
       e) Holding and transporting eggs at or below 45 degrees Fahrenheit beginning 36 hours after time of lay.

     Your written response does not include a written plan that addresses procurement of pullets, a biosecurity program, and procedures for cleaning and disinfecting the poultry house.   Regarding pest control, your response provides an overview of your programs.  It does not include information on how you will monitor by visual inspection of rodents, in addition to the mechanical monitoring method, as required by 21 CFR 118.4(c). 

     Regarding refrigeration, your response states that you plan to change the threshold “very soon” for refrigeration of shell eggs and that your cooler temperature needs to be (b)(4) degrees.  You further state that if the temperature exceeds (b)(4) degrees for (b)(4) hours and your unit is not fixed, you will “(b)(4).”  Your response is inadequate, as you must hold and transport eggs at or below 45 degrees Fahrenheit beginning 36 hours after the time of lay, as required by 21 CFR 118.4(e).  Furthermore, during the inspection you indicated that you do not check cooler temperatures during the (b)(4).  You must maintain continuous refrigeration of shell eggs 36 hours after the time of lay and maintain records documenting refrigeration, as required by 21 CFR 118.10(a)(3)(iv).  We also note that you documented a temperature range of (b)(4) degrees Fahrenheit rather than an exact temperature on your refrigeration records.  You must record the actual values observed, as required by 21 CFR 118.10(b)(4).  
 
     We will verify the adequacy of your pest control program and documentation of compliance with refrigeration requirements of your shell eggs during the next inspection of your farm. 

     2. Your firm failed to conduct environmental testing for SE in your poultry house when laying hens were 40 to 45 weeks of age, as required by 21 CFR 118.5(a).  Your environmental testing record dated November 25, 2016, for flock (b)(4) shows that the flock was tested at (b)(4) weeks of age.  In addition, you were unable to provide documentation showing that environmental testing for SE was conducted on subsequent flocks (flock (b)(4) and flock (b)(4)) when laying hens were 40-45 weeks of age (b)(4) and (b)(4) respectively).  

     Your response states that going forward you intend to mark your calendar at (b)(4) weeks of age.  We will evaluate the sufficiency of your testing and documentation during the next inspection. 

     3. You do not have documentation that you procured pullets that were SE-monitored or were raised under SE-monitored conditions, including environmental testing records for pullets, as required by 118.4(a)(2), to comply with 21 CFR 118.10(a)(2).  Specifically, you could not provide any documentation to show your flock (b)(4) pullet environment was tested for SE when they were 14 to 16 weeks of age.  

Your response states that you will let your pullet grower “know” and make sure testing is done at (b)(4) weeks.  It is your responsibility, as a producer, to verify that the pullet environment is tested at 14-16 weeks of age.  When developing your SE plan, you should include verification that you are receiving pullets raised under SE-monitored conditions, including testing at required timeframes.  We will evaluate the sufficiency of the testing and your documentation during the next inspection. 

The above violations are not meant to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your shell egg production facility operates in compliance with all applicable statutes and regulations, including the Act, the PHS Act, and the Shell Egg regulation.  You are also responsible for using procedures to prevent future violations of these statutes and regulations.  You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).  If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

In addition to the above violations, we also have the following comment:

We reviewed your most recent environmental testing record which is dated November 25, 2016, and it indicates that you obtained (b)(4) swabs from your (b)(4) house.  (b)(4) swabs is not a sufficient number of swabs to be representative of the environment.  The FDA recommends the collection of at least ten swabs, which is dependent on your (b)(4) poultry house size, to obtain a representative sample in the environment.  Please refer to FDA’s December 2011, Guidance for Industry on “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation,” www.fda.gov/media/82653/download, for additional information.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 15 working days of receiving this letter.  Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence.  If corrective action cannot be completed within 15 working days of receiving this letter, state the reason for the delay and the timeframe within which the corrections will be completed.  Please include copies of any available documentation demonstrating that corrections have been made.  If you do not believe that your products are in violation of the Acts, include your reasoning and any supporting information for our consideration.

Please send your written response to Dianna C. Sonnenburg, Compliance Officer, U.S. Food and Drug Administration, at 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota, 55401.  If you have any questions regarding any issues in this letter, please contact Ms. Sonnenburg at (612) 758-7125.

Sincerely,
/S/
Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Food Operations

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