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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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K-Brand Farms 4/3/12

  

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

Public Health Service
Food and Drug Administration
 
New York District
158-15 Liberty Avenue
Jamaica, NY 11433  

 

April 03, 2012
 
WARNING LETTER NYK-2012-09
 
 
VIA UNITED PARCEL SERVICE
 
Mr. Robert L. Kaplan
Co-Owner / Plan Administrator
K-Brand Farms                                                                      
715 Glen Wild Road
Woodridge, NY 12789
 
Dear Mr. Kaplan:
 
The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at 715 Glen Wild Road; Woodridge, NY 12789 on November 30, 2011 through December 2, 2011. During the inspection the 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 FFD&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 FFD&C Act, the PHS Act, and the shell egg regulation through links on FDA’s home page at www.fda.gov.
 
We received your response dated December 5, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to you at the close of the inspection. We address this response below, in relation to the noted violations.
 
Your significant violations were as follows:
  1. Failure to maintain records documenting compliance with biosecurity measures, as required by 21 CFR 118.10(a)(3)(i). Specifically, your “K-Brand Farms Salmonella Enteritidis Prevention Plan” includes the following biosecurity measures for which your firm does not maintain records documenting compliance:
  • Disinfection of tools prior to being transported between poultry houses;
  • Maintenance of traps to monitor stray animal activity;
  • Policy that employees are not allowed to maintain birds at home;
  • Employee training relating to issues of biosecurity; and,
  • Visitor and contractor guidelines relating to biosecurity.
 
The adequacy of your firm’s response cannot be determined at this time. Your response is simply a promise to correct the violation. No time frame for completing corrective action was given and no supporting documentation was submitted at the time of the response.
  1. Failure to maintain records documenting compliance with refrigeration requirements, as required by 21 CFR 118.10(a)(3)(iv).  Specifically, with respect to your delivery trailers, you do not maintain records documenting compliance with 21 CFR 118.10(a)(3)(iv), which requires that you hold and transport eggs at or below 45°F ambient temperature beginning 36 hours after time of lay (a requirement that is reflected in the “Refrigeration Requirements” section of your SE prevention plan). You load the trailers with product on one day and use the trailers to transport the product on the following day, but you do not monitor and record the temperature on the trailers.   We also note that your SE plan lacks a corrective action procedure for determining the disposition of affected eggs if the temperature exceeds 45°F.
The adequacy of your firm’s response cannot be determined at this time. Your response is simply a promise to correct the violation. No time frame for completing corrective action was given and no supporting documentation was submitted at the time of the response.
  1. Failure to prevent stray animals from entering poultry houses, as required by 21 CFR 118.4(b)(4).  Specifically, on December 1, 2011 the following was observed:
  • Live cats were observed in both the Baker and Yussel houses;
  • Bird wire was observed to be missing on the exteriors of both layer houses; and,
  • Rodent remains were observed in the Yussel layer house.
 
Your firm’s response is inadequate in that it states: “Even though the exterior of our buildings is inspected twice a year, cats still manage to enter buildings during clean out in Spring and Fall.”  It appears from your aforementioned statement that your current process is not effectively excluding cats, or other stray animals, from your poultry houses.  As part of your biosecurity program, you must prevent stray poultry, wild birds, cats, and other animals from entering your poultry houses. 
 
Your firm’s response further stated that you had notified your contractor of the missing bird wire, and would have that matter taken care of shortly.  We will evaluate that corrective action during a subsequent inspection. In addition, the corrective actions for the rodent remains will be evaluated during a subsequent inspection.
  1. Failure to remove debris within a poultry house and vegetation and debris outside a poultry house that may provide harborage for pests, as required by 21 CFR 118.4(c)(3).  Specifically, on December 1, 2011, piles of clothing, tools, building materials, equipment, tires, general refuse, crates, pallets, boxes, food containers and an abandoned vehicle were observed around the exterior of the buildings.  Piles of tools, equipment, clothing/shoes, building materials, food refuse, crates, discarded eggs and feed were observed inside the layer houses. While some of the harborage observed during the inspection was associated with poultry houses that did not contain birds at the time of the inspection, your poultry houses are connected by enclosed walkways to the egg processing plant, and as you acknowledged in your response, rodents from surrounding areas could go into your layer houses.
The adequacy of your firm’s response cannot be determined at this time. Your response is simply a promise to correct the violation. No time frame for completing corrective action was given. The corrective action will be evaluated during a subsequent inspection.
  1. Failure to include the time of the activity that the records reflect on all of your required records, as required by 21 CFR 118.10(b)(2). Specifically, none of the records observed during the current inspection documented the time activities were performed.
The adequacy of your firm’s response cannot be determined at this time. Your response is simply a promise to correct the violation. No time frame for completing corrective action was given.  The corrective action will be evaluated during a subsequent inspection.
  1. Failure to include the name and the location of your farm on all required records, as required by 21 CFR 118.10(b)(1).  Specifically, many of the records we observed during our inspection did not include the firm name and address.
The adequacy of your firm’s response cannot be determined at this time. Your response is simply a promise to correct the violation. No time frame for completing corrective action was given. The corrective action will be evaluated during a subsequent inspection.
  1. Failure to sign and date the written SE plan as required by 21 CFR 118.10(b)(3).  Specifically, your firm’s SE plan is not signed and dated by the person who administers the plan as described in 21 CFR 118.9.
The above violations are 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 FFD&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.
 
In addition to the above violations, we also have the following comments based on our review of your firm’s SE plan as well as our inspection of November 30 through December 2:
 
  • Your corrective action of increasing the number of bait stations and amount of bait for rodent control is inadequate in that it allows for more rodents to be caught, but does not gain control over an increasing rodent population.
  • We note that Appendix VII of your firm’s SE plan references the use of a procedure entitled “Salmonella Enteritidis Boot Swab Sampling for Cage-Free and Organic Chickens”; however, no scientific data or studies were provided to show this is an equivalent method in accuracy, precision and sensitivity in detecting SE to the method cited in 21 CFR 118.8(a). We encourage you to submit additional documentation to FDA, so that we can determine if the boot swab sampling method cited in your SE plan is equivalent in accuracy, precision, and sensitivity in detecting SE.
  • Your biosecurity procedure guidelines for foot pans do not address the maintenance of the foot pans and foot pan sanitizing agents to 1) ensure continued effectiveness of the disinfectant/sanitizing agent used in the foot pans and 2) check for visible/excessive organic matter in the foot pans, as was observed by our investigators on December 1, 2011, in the Baker and Yussel houses. Physical barriers such as foot pans – used in conjunction with methods to prevent airborne transmission of SE – are especially important if one or more of your poultry houses were to have a positive environmental test result. In order to effectively make use of foot pans as one means of preventing cross contamination in the event of an SE-positive environment in one of your poultry houses, your SE plan should specify how often foot pans would be maintained in such a situation (including a maintenance log) and what chemical would be used at what concentration.
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.  You should include in your response documentation and other useful information that would assist us in evaluating your corrections.  If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the time within which the remaining corrections will be completed.
 
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).
 
Your written response should be sent the Food and Drug Administration; Attention:
 
LCDR Frank Verni
Compliance Officer
U. S. Food and Drug Administration
158-15 Liberty Avenue, Room 4050
Jamaica, NY 11433
 
If you have any questions about the content of this letter please contact:  LCDR Verni at (718) 662-5702.
 
Sincerely,
/S/                                                                                   
Ronald M. Pace
District Director
New York District
 
 
cc: Mr. Philip Kaplan
      Co-Owner
      K-Brand Farms                                                                
      715 Glen Wild Road
      Woodridge, NY 12789