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  5. Elmer Yoder - 01/15/2014
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WARNING LETTER

Elmer Yoder


Recipient:
Elmer Yoder


United States

Issuing Office:
Kansas City District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Kansas City District
Southwest Region
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100 

January 15, 2014
 

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ref.- 2014-05
 

Elmer Yoder, Owner
Elmer Yoder
3102 195th Street
Lockridge, IA 52635
 

Dear Mr. Yoder:
 

The U.S. Food and Drug Administration (FDA) inspected your shell egg production facility, Elmer Yoder, 3102 195th Street, Lockridge, IA 52635, on September 10-12, 2013. During the inspection, FDA found that your facility had significant 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 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 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 http://www.fda.gov.
 

Your significant violations are as follows:
 

1.    You failed to prevent wild birds from entering the poultry house as required by 21 CFR 118.4(b)(4). Specifically, we observed three wild birds on 9/11/13 in the rafters of the firm's poultry house. We also observed two holes, three inches in diameter in the screens on the south end of the poultry house and two gaps on the ends of the metal screens used in one of the openings on the north side of the poultry house that were a quarter inch by two feet in size.
 

2.    Your firm's written SE prevention plan is inadequate in that it does not include all of the SE prevention measures required by 21 CFR 118.4. Specifically, your written SE prevention plan does not address prevention of stray poultry, wild birds, cats and other animals from entering your poultry house, as required by 21 CFR 118.4(b)(4).
 

3.    You failed to fully implement your written SE prevention plan as required by 21 CFR 118.4.
 

Specifically, our investigators made the following observations:
 

o    There was no visual or physical inspection of the facility performed and documented (b)(4) for rodents as required by the firm's SE Prevention Plan on:
 

• 1/7/13
• 1121113
• 1/28/13
• 2/2/13
• 2116113
• 2/23/13
• 2/30/13
• 7/3/13-8/23/13
 

o    There was no (b)(4) fly monitoring performed and documented as required by the firm's SE Prevention Plan from 7/3/13-8/23/13 and 8/31/13.
 

o    As part of your fly monitoring procedure, your plan instructs employees to "Walk for approximately (b)(4) feet through the house, or for about (b)(4), in order to expose the tape to a representative sample of flies." However, you stated that the moving fly tape method you implement consists of walking across the front of the house ((b)(4) feet), down one side of the poultry house ((b)(4) feet), across the rear of the house ((b)(4) feet), and back up the other side ((b)(4) feet), which equals approximately (b)(4) feet, which you said took about a (b)(4). Please note that under 21 CFR 118.4, your written SE prevention plan must be specific to your farm.
 

o    Your Rodent Control Corrective Action Log has an entry on 11/10 (apparently for the year 2012) where your firm exceeded the rodent threshold by having a rodent index (RI) of (b)(4), yet under the "Action Taken" it states "nothing." Your written SE prevention plan indicates that a corrective action should be taken to decrease the rodent population whenever a rodent index greater than (b)(4) is found.
 

4.    You failed to maintain records documenting your rodent and other pest control measures, as required by 21 CFR 118.10(a)(3)(ii). Specifically, your 'rodent/pest control log" is missing rodent monitoring dates for June, July, August, September, and October 2012. For producers such as yourself with fewer than 50,000 but at least 3,000 laying hens, the compliance date for the shell egg regulation was July 9, 2012. From July 9, 2012 to November 2012, you did not maintain records documenting your rodent monitoring.

The above identification of violations is not intended to be an all-inclusive list of deficiencies at your facility. As a shell egg producer, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with all applicable statutes and regulations, including the PHS Act, the FD&C Act, and the shell egg regulation.
 

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:
 

•    We are concerned that the temporary help you rely on when you are away from the farm may introduce SE to your egg laying house. Please be aware that under 21 CFR 118.5(b )(5), egg laying farm employees are not allowed to keep birds at home. This biosecurity measure is intended to protect against cross-contamination when persons enter an egg laying house. You should consider what preventive controls you can implement in order to protect your temporary help from introducing SE into your egg laying house.
 

Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, of the steps you have taken to correct the violations noted above. Your response should include each step you have taken or will take to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) 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 that would assist us in evaluating your corrections.

Your response should be sent to Jessica E. Hensley, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 8050 Marshall Dr., Suite 205, Lenexa, Kansas 66214. If you have any questions about this letter, please contact Compliance Officer, Jessica E. Hensley at 913-495-5183.
 

Sincerely,
 

/S/

Dr. Ann M. Adams
Acting District Director
Kansas City District Office

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