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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Warren Farms LLP 12/28/12

  

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

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
 
Telephone: (615) 366-7801
FAX:   (615) 366-7802

 

December 28, 2012
 
WARNING LETTER NO. 2013-NOL-05
 
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Mr. Ira Vaughn Warren, Owner
Warren Farms, LLP
799 Dove Circle
Union Grove, AL 35175-8342
 
Dear Mr. Warren:
 
On August 7-9, 2012, a U.S. Food and Drug Administration (FDA) investigator inspected your shell egg production facility located at 799 Dove Circle, Union Grove, Alabama.  During the inspection, FDA found that your facility had 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 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 presented to you on form FDA-483, Inspectional Observations, at the conclusion of our inspection on August 9, 2012.  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 received your firm’s response to the form FDA-483 on August 29, 2012, and our evaluation of your response is discussed below.  
 
Your significant violations are as follows:
 
  1. You failed to maintain records documenting your procedures for environmental sampling performed under 21 CFR 118.7, as required by 21 CFR 118.10(a)(3)(v).  Specifically, your records failed to document your sampling plan.   

We reviewed your response to the FDA-483 received on August 29, 2012.  You stated you “have made and are in the process of making further adjustments to [your] SE prevention plan to include environmental sampling and records of these procedures.” However, you failed to include with your response your revised SE Prevention Plan or any records documenting your procedures for environmental sampling performed under 21 CFR 118.7.  We will evaluate the adequacy of your corrective action during our next inspection of your farm.  

  1. You failed to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses, as required by 21 CFR 118.4(b)(4).  Specifically, our investigators observed a dog enter the south side of house 1 and jump over the conveyor belt transporting eggs to the packing area.  In addition, your firm’s SE Prevention Plan states your houses are equipped with (b)(4) to prevent wild animals and birds from entering.  However, our investigators observed (b)(4) between houses and (b)(4) on the houses.
  1. You failed to maintain records documenting compliance with biosecurity measures, as required by 21 CFR 118.10(a)(3)(i).  Specifically, your SE Prevention Plan states your employees are required to sign an agreement stating they will not own birds. However, you were unable to provide any of these agreements to our investigators. In addition, from July 9, 2010, through January 2012, your firm did not maintain records of any biosecurity measures.
 
We reviewed your response to the FDA-483 received on August 29, 2012.  You stated you are in the process of having each employee sign an agreement stating they will not own a bird of any type while employed at your facility.  We will verify this correction during our next inspection of your farm.
 
  1. You failed to have and implement a written SE Prevention Plan that includes an appropriate monitoring method for flies, as required by 21 CFR 118.4(c)(2).  Specifically, your firm’s SE Prevention Plan states (b)(4) are used as needed to “achieve acceptable fly activity,” but it does not specify a fly monitoring method or define what level of fly activity is acceptable. We note no (b)(4) were observed in the layer houses during the inspection.  You also failed to maintain records documenting your fly monitoring activities, as required by 21 CFR 118.10(a)(3)(ii). We note if you do not monitor for flies, you cannot make a determination of whether fly activity is unacceptable, as required by 21 CFR 118.4(c)(2).   
 
We reviewed your response to the FDA-483 received on August 29, 2012.  You stated you have modified your SE Prevention Plan to include (b)(4) monitoring of (b)(4) by (b)(4). You stated if the number of flies per (b)(4) is less than (b)(4), it would be considered normal and acceptable fly activity.  You also provided details about the corrective actions you would take for various fly counts above (b)(4). However, your response did not include a revised SE Prevention Plan or provide any supporting documentation demonstrating you implemented these fly monitoring procedures.  We will evaluate the adequacy of your corrective action during our next inspection of your farm.  
 
  1. You failed to comply with the general requirements—set forth in 21 CFR 118.10(b)—for all records required by 21 CFR 118.10(a). Specifically, under 21 CFR 118.10(b)(2), such records must include the date and time of the activity that the record reflects; but your rodent trap records do not include the time when monitoring was performed, and your inside bait stations forms do not include the year when monitoring was performed. Furthermore, under 21 CFR 118.10(b)(4), data and information reflecting compliance activities must be entered on such records at the time the compliance activity is performed or observed; but during our inspection your foot wash check sheets contained dates and times for monitoring activities that had not yet occurred, and your cooler temperature checklist forms contained preprinted times, including for monitoring activities that had not yet occurred.  
 
We reviewed your response to the FDA-483 received on August 29, 2012. You stated you are making changes to the documentation listed above in order to comply with the relevant requirements, but you did not provide any supporting documentation demonstrating you implemented these changes. We will evaluate the adequacy of your corrective action during our next inspection of your farm.
 
  1. You failed to include in your required records the signature or initials of the person performing the operation or creating the record, as required by 21 CFR 118.10(b)(3).  Specifically, your rodent trap monitoring records did not have the signature or the initials of the employee performing the operation.
 
We reviewed your response to the FDA-483 received on August 29, 2012. You stated the date, time, and the initials of the employee will be added to each check sheet in your SE prevention program. However, you did not provide any supporting documentation demonstrating you made these revisions to your required records.  We will evaluate the adequacy of your corrective action during our next inspection of your farm.
 
This letter is not intended 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 a responsibility to use procedures to prevent further 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).
 
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you have done or plan to do to correct these violations and prevent their recurrence.  Your response should include any documentation necessary to show that corrective action has been achieved, including your revised SE Prevention Plan and any other documentation demonstrating you have corrected the violations. If you cannot complete all corrections within 15 working days, state the reason for your delay and the time within which the remaining corrections will be completed. 
 
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-1(a)(2)(B)]. For domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Please send your written reply to this letter to the U.S. Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 832-1290, extension 1103.
                                                                        
Sincerely,       
/S/ 
Patricia K. Schafer
District Director
New Orleans District