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WARNING LETTER

Cedar Creek Egg Company, LLC MARCS-CMS 507819 —


Recipient:
Cedar Creek Egg Company, LLC


United States

Issuing Office:
Kansas City District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Kansas City District Office
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
CMS Case # 507819
 
November 8, 2016
 
Mr. Steven F. Flieg, Owner
Cedar Creek Egg Company LLC
13584 Cedar Creek Rd
Sainte Genevieve, MO 63670-8955
 
Dear Mr. Flieg:
 
The United States Food and Drug Administration (FDA) inspected your shell egg production farm located at 13584 Cedar Creek Rd, Sainte Genevieve, Missouri on August 23-25, 2016 and again on September 13-15, 2016. During the inspection, we 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 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 Form FDA 483, Inspectional Observations, which was issued to you on August 25, 2016.  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 are in receipt of your firm’s September 8, 2016 response 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 have and implement a written Salmonella Enteritidis prevention plan (“SE Plan”) as required by 21 CFR 118.4. Specifically, your written SE prevention plan, failed to include the following required SE prevention measures:
 
A.  You firm failed to have and implement procedures to ensure pullets are raised under SE monitored conditions, including environmental testing, as required by 21 CFR 118.4(a). Specifically, you do not have documentation verifying your pullets received from (b)(4) located in (b)(4) on or about March 2015 were tested for SE between 14 and 16 weeks of age as required by 21 CFR 118.4(a)(2).
 
We are in receipt of your firm’s September 8, 2016 response, in which you promise to develop an SE Plan; however, you have not provided this new plan and your response does not discuss procedures to ensure pullets are raised under SE monitored conditions, including environmental testing. We will evaluate the adequacy of your corrective actions during our next inspection of your farm.
 
B.  Your SE prevention plan failed to include biosecurity measures that will protect against cross contamination when persons move between poultry houses, as required by 21 CFR 118.4(b)(3). For example, there are no foot bathes at the entrance to the hen houses, dedicated boots, garments or other procedures to prevent cross contamination. In addition, during the August 23-25, 2016 inspection you provided our investigators with the "Policy for Visitors" section of your SE Plan; however, this section was incomplete and lacking in detail. For example, your SE plan did not establish specific practices to prevent cross contamination or the logging of visitors to the farm.
 
We are in receipt of your firm’s September 8, 2016 response, in which you promise to develop an SE Plan; however, you have not provided this new plan and your response does not discuss appropriate biosecurity measures. We will evaluate the adequacy of your corrective actions during our next inspection of your farm.
 
C.  Your SE prevention plan failed to include an appropriate monitoring method for rodents, as required by 2 CFR 118.4(c)(1). Specifically, you told investigators that you do not monitor for the presence of rodents in your egg laying houses. Further, your plan does not provide a threshold level of unacceptable rodent activity within a poultry house, and, when monitoring indicates unacceptable rodent activity, the methods you will use to achieve satisfactory rodent control as required by 21 CFR 118.4(c)(1). Without a threshold, such as rodent indexing, it is impossible to determine what an unacceptable level of rodent activity is. 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. See http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Eggs/ucm285101.htm
 
In addition, although part of your SE plan "Policy for Rodent and Fly Control” states that the outside is to be properly maintained, on August 25, 2016, our investigators observed vegetation (what appears to be a garden) and debris between house (b)(4) that allow harborage conditions. Please note that you must remove debris within a poultry house and vegetation and debris outside a poultry house that may provide harborage for pests in order to comply with 21 CFR 118.4(c)(3).
 
We are in receipt of your firm’s September 8, 2016 response, in which you promised to revise your SE plan to include a template for a rodent activity log, and state that you have added traps in various locations in and around your egg laying houses. However, you have not provided this new plan or a completed rodent log and your response does not discuss how the monitoring will be conducted or how the rodent index will be determined.  In addition, you do not state how you will address harborage conditions. We will evaluate the adequacy of your corrective actions during our next inspection of your farm.
 
D.  You failed to have and implement an SE prevention plan that includes an appropriate monitoring method for flies, as required by 21 CFR 118.4(c)(2). Specifically, on August 25, 2016, you informed our investigators that you do not monitor for the presence of flies in your egg laying houses. Further, your plan does not provide a threshold level of unacceptable fly activity within a poultry house, and, when monitoring indicates unacceptable fly activity, the methods you will use to achieve satisfactory fly control, as required by 21 CFR 118.4(c)(2). Without a threshold, such as the spot card index, it is impossible to determine an unacceptable level of fly activity. We note that FDA’s December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” recommends several procedures for obtaining an appropriate characterization of levels of fly activity.
 
In addition, although part of your SE plan "Policy for Rodent and Fly Control” states that the outside is to be properly maintained, on August 25, 2016, our investigators observed vegetation (what appears to be a garden) and debris between house (b)(4) that allow harborage conditions. Please note that you must remove debris within a poultry house and vegetation and debris outside a poultry house that may provide harborage for pests in order to comply with 21 CFR 118.4(c)(3).
 
We are in receipt of your firm’s September 8, 2016 response, in which you promised to revise your SE plan to account for fly control, and state that you have added traps in various locations in and around your egg laying houses. However, you have not provided this new plan or a completed fly log, and your response does not discuss how the monitoring will be conducted or how satisfactory fly control will be achieved. In addition, you do not state how you will address harborage conditions. We will evaluate the adequacy of your corrective actions during our next inspection of your farm.
 
E.  Your SE prevention plan failed to include appropriate procedures for cleaning and disinfecting the poultry house before new laying hens are added to the house when there is an environmental test or an egg test that was positive for SE at any point during the life of a flock that was housed in the poultry house prior to depopulation, as required by 21 CFR 118.4(d). Specifically, during the August 23-25, 2016 inspection you provided to our investigators with the "Policy for House Cleaning and Disinfection" section of your SE plan, however, this section was incomplete and lacking in detail.
 
We are in receipt of your firm’s September 8, 2016 response, in which you promise to develop an SE Plan; however, you have not provided this new plan and your response does not discuss appropriate procedures for cleaning and disinfecting the poultry houses. We will evaluate the adequacy of your corrective actions during our next inspection of your farm.
 
2.    Your firm failed to conduct environmental testing for SE when your flocks of laying hens reached 40 to 45 weeks of age as required by 21 CFR 118.5(a). Specifically, you populated house number (b)(4) with approximately (b)(4) birds hatched on or about 12/3/14, however, this house was not sampled for SE until (b)(4) when the birds were approximately 56 weeks old. In addition, you populated house number (b)(4) with approximately (b)(4) birds hatched on or about 4/14/14, however, this house was not sampled for SE until (b)(4) when the birds were approximately 89 weeks old.
 
We are in receipt of your firm’s September 8, 2016 response, in which you promise to develop an SE Plan; however, you have not provided this new plan and your response does not discuss environmental testing of houses (b)(4). We will evaluate the adequacy of your corrective actions during our next inspection of your farm.
 
3.    Your firm failed to maintain records documenting your SE prevention measures as required by 21 CFR 118.10. Specifically:
 
A.  You did not maintain records documenting compliance with refrigeration requirements as required by 21 CFR 118.10(a)(3)(iv). Specifically, you informed our investigators on August 25, 2016, that you do not have refrigeration or cooling logs which document eggs were held at or below 45 degrees F beginning 36 hours after time of lay prior to May 2016. Additionally, you have not maintained any logs documenting the temperature of your (b)(4) before or during the conveyance of eggs.
 
B.  You did not maintain records documenting environmental procedures as required by 21 CFR 118.10(a)(3)(v). Specifically, for the environmental samples collected on or about (b)(4) at houses (b)(4), you do not maintain any records of how the sample was collected or any records that provide any detail as to the method used in the analysis of the samples.
 
We note that the results page provided by the lab identifies the method used as “FDA”; however, you did not provide any records to describe whether the method used to test the sample was the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses" or an equivalent method in accuracy, precision and sensitivity in detecting SE as required by 21 CFR 118.8.
 
We are in receipt of your firm’s September 8, 2016 response, in which you state that you have “developed several logs to record things such as . . . (b)(4) temp during transport,” however you have not provided any of these logs and your response does not discuss maintain records documenting your SE prevention measures in any detail. We will evaluate the adequacy of your corrective actions during our next inspection of your farm.
 
4.    Your firm failed to have qualified supervisory personnel who are responsible for development and implementation of an SE plan that is appropriate for your farm and meets the regulatory requirement as required by 21 CFR 118.9. Specifically, on August 25, 2016, you informed our investigators Mr. Steven Flieg is the supervisory person responsible for monitoring the development and implementation of a SE Plan; however, this is not documented.
 
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 above violations we offer the following comment:
 
During the September 13-15, 2016 our investigators observed (b)(4) containing a (b)(4). However, we have concerns that you are not following the manufacturer’s instructions for use of this and therefore this practice may not adequately protect against cross contamination when persons move between poultry houses.
 
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that corrective action has been achieved, such as a revised SE Prevention Plan and monitoring records. If you cannot complete all corrections within fifteen (15) working days, you should explain the reason for your delay and the time within which the remaining corrections will be completed.
 
Please send your reply to the attention:
 
Miguel Hernandez
Director, Compliance Branch
U.S. Food and Drug Administration
Kansas City District
8050 Marshall Drive
Suite 205
Lenexa, Kansas 66214
  
If you have any questions regarding any issue in this letter, please contact Danial S. Hutchison, Compliance Officer at 913-495-5154.
  
 
Sincerely,
/S/
Cheryl A. Bigham
District Director
Kansas City District
 
Cc:
 
Linda Hickman
State Veterinarian
Missouri Department of Agriculture
PO Box 630
Jefferson City, MO  65102
 
Eric Hueste
Bureau Chief
Missouri Department of Health and Senior Services
912 Wildwood, PO Box 570
Jefferson City, MO  65102-0570