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WARNING LETTER

Walnut Ridge Farm 1 MARCS-CMS 564117 —

Product:
Food & Beverages
Egg/Egg Product

Recipient:
Recipient Name
Mr. Samuel T. Peachey
Recipient Title
Owner
Walnut Ridge Farm 1

1657 Pitcher Road

Ovid, NY 14521-9799
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


WARNING LETTER

CMS #564117

 

2/12/19 

 

VIA UNITED PARCEL SERVICE

DELIVERY SIGNATURE REQUESTED

 

Mr. Samuel T. Peachey, Owner

Walnut Ridge Farm 1

1657 Pitcher Road

Ovid, NY 14521-9799

 

Dear Mr. Peachey:

The United States Food and Drug Administration (FDA) inspected your shell egg farm, located at 1657 Pitcher Road, Ovid, NY, 14521 from August 1 through August 2, 2018. During the inspection, the investigators observed that you have serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR 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 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. Our investigators’ observations were noted on the FDA 483, Inspectional Observations, which was issued to you on August 2, 2018. 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 acknowledge receipt of your response dated August 17, 2018 concerning our investigator’s observations issued to you at the close of the inspection. Our evaluation of your response is discussed below.

Your significant violations are as follows:

1.    Your firm failed to implement a written, farm-specific Salmonella Enteritidis prevention plan (“SE Plan”) as required by 21 CFR 118.4. Specifically, on August 1, 2018, you provided a written SE Plan that was provided to you by your egg distributor. However, this SE Plan only contains general information that is not specific to the operations or procedures of your farm. For example, this plan states the number of environmental swabs that must be taken based on the size of the poultry house but does not specify the size of your poultry house. The plan does not address practices to prevent cross contamination for the specific equipment used on your farm and the places where that equipment is used and stored. The plan does not provide specific cleaning and disinfecting procedures for your poultry house or specify how the refrigeration requirements actually occur at your farm. Your SE plan does not include a written “No Birds at Home Policy.”

We have reviewed your response, dated August 17, 2018. In your response, you stated that the “SE Plan will be updated to make more Farm specific” and provided part of an updated SE Plan. However, this updated SE Plan is inadequate because the measures are still not specific to your farm and do not describe how your farm complies with all prevention measures required under 21 CFR 118.4, including specific cleaning and disinfecting procedures for your poultry house, specific refrigeration procedures, and a written “No Birds at Home Policy.”

2.    Your firm failed to test the pullet environment at 14-16 weeks of age as required by 21 CFR 118.4 (a)(2)(i). Based on date of hatch of the chicks (November 10, 2017), a test of the pullet environment should have been conducted sometime between February 17, 2018 through March 3, 2018. However, you could not provide any documentation to show that the pullet environment was ever tested for SE for your current flock that you received from the pullet grower at 17 weeks of age.

We have reviewed your response, dated August 17, 2018. In your response, you stated that “pullets that are bought for this farm will have SE test done at 14 to 16 weeks of age.” We will evaluate the sufficiency of your testing and documentation during the next inspection.

3.    Your firm failed to maintain records documenting compliance with the SE prevention measures as required by 21 CFR 118.10. Specifically, your firm did not maintain records that detail compliance with SE preventive measures to prevent cross contamination from equipment used in more than one poultry house (21 CFR 118.10(a)(3)(i)).

We have reviewed your response, dated August 17, 2018. Your response states that equipment cleaning will be documented. Because you have not provided us with any documentation, we are unable to evaluate the adequacy of your response. We will evaluate the sufficiency of your documentation during the next inspection. We note that FDA’s December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” provides example of records documenting compliance with SE preventative measures. See   http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Eggs/ucm285101.htm. For example, biosecurity records may include cleaning and disinfection logs for equipment shared among poultry houses.

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 FD&C Act, the PHS Act, and the shell egg regulation. You also have the responsibility to use 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).

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

  • In your August 17, 2018 response, you stated that “Rodent bait stations will be placed outdoors and monitored every (b)(4).” We note that rodent monitoring is required in the poultry house and in outdoor access areas that are part of the poultry house (as defined by 21 CFR 118.3). For additional information on rodent monitoring for layers with outdoor access, see Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Outdoor Access), July 2013, https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm360028.htm. To the extent this regulation applies to your outdoor access areas, we note that FDA’s December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” recommends a procedure for obtaining a rodent index of rodent activity based on rodents caught within a 7-day period. See   http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Eggs/ucm285101.htm.  

Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. As stated above, 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, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made. If you believe you have complied with FDA regulations, include your reasoning and any supporting information for our consideration.   

Please send your reply to the U.S. Food and Drug Administration, Attention: Michael R. Dominick, Compliance Officer, 222 Bloomingdale Road, Suite 406, White Plains, NY 10601. If you have questions regarding any issues in this letter, please contact Michael R. Dominickat 914-682-2826 ext. 20 or email at Michael.Dominick@fda.hhs.gov.

Sincerely,

/S/ 

Ronald Pace                                                   

Program Division Director

Office of Human and Animal Food Operations -

East Division 1