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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mikilua Poultry Farm Inc. 12/16/11

  

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

Public Health Service
Food and Drug Administration
 
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700 

 

WARNING LETTER
 
VIA UPS
Signature Required

December 16, 2011
 
Phyllis S. Shimabukuro-Geiser, President
Mikilua Poultry Farm Inc.
1612 A Kilohi St.
Honolulu, HI, 96819
 
Dear Ms. Shimabukuro-Geiser:
 
The United States Food and Drug Administration (FDA) inspected your four shell egg production facilities located at 87-550 Kaukama Road, 87-730 Kaukama Road, 87-925 Paakea Road, and 87-897 Apuupuu Road, Waianae, Hawaii, on September 12th through 16th, 2011. During the inspection, FDA found that your facilities had serious violations of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR 118). Egg production at your farms must comply with all of the requirements of 21 CFR 118, which applies to farms where any of the eggs produced at the farm do not receive a treatment as defined in 21 CFR 118.3. 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
 
Your significant violations were as follows:
 
1.      You failed to have a written SE Prevention Plan that includes, at a minimum, the SE prevention measures required by 21 CFR 118.4. Specifically, during our inspection your SE prevention plan, titled “Mikilua Poultry Farm Inc. Egg Quality Assurance Plan,” failed to include the following required SE prevention measures:
    • The section titled “Rodent and Insect Control” failed to include procedures to monitor for rodents and flies. Your SE Prevention Plan must address monitoring for rodents by visual inspection and mechanical traps or glueboards or another appropriate monitoring method, as required by 21 CFR 118.4(c)(1). In addition, your SE Prevention Plan must address monitoring for flies by spot cards, Scudder grills, or sticky traps or another appropriate monitoring method, as required by 21 CFR 118.4(c)(2).
Having reviewed the updated SE Prevention Plans included in your undated written response, received October 7, 2011, we have multiple concerns with your updated rodent and fly monitoring procedures. Your fly monitoring procedure includes counting the number of flies captured on a sticky tape after employees walk through 1,000 ft of poultry house. However, your procedure does not include the frequency of fly monitoring, the length of the sticky tape, or the threshold at which a corrective action would be necessary, i.e. number of flies observed on the sticky tape. Also, your rodent monitoring procedure does not include the monitoring frequency or the parameters by which you define “satisfactory” rodent control. Your updated SE Prevention Plans indicate that you will monitor for rodents via visual inspection and mechanical trapping; however, you do not describe exactly what “mechanical trapping” will entail, e.g. where will your traps be placed? How far apart will they be placed? How will you convert the number of rodents caught into some rodent population context so as to determine when monitoring indicates unacceptable rodent activity?
    • At the time of our inspection, the section of your SE prevention plan titled “Biosecurity” failed to include practices that will protect against cross contamination when equipment is moved among poultry houses, as required under 21 CFR 118.4(b)(2); practices that will protect against cross contamination when persons move between poultry houses, as required under 21 CFR 118.4(b)(3); and a requirement that employees not be allowed to keep birds at home, as required under 21 CFR 118.4(b)(5).
We note that the updated SE Prevention Plans included in your undated written response, received October 7, 2011, cite the Biosecurity measures referenced above. However, with respect to the requirement that employees not be allowed to keep birds at home, the plans  do not provide any explanation as to how this policy will be communicated and enforced. With respect to practices that protect against cross contamination when equipment is moved among poultry houses, the one practice described in your updated SE Prevention Plans – spraying equipment tires with an anti-bacterial solution – does not appear adequate. Biosecurity measures should account for the fact that Salmonella Enteritidis can be transmitted through airborne routes. Therefore, your measures should address the entirety of specific pieces of equipment and not just the tires. Similarly, with respect to practices that protect against cross contamination when employees move between poultry houses, your updated plans state only that employees spray their footwear with an anti-bacterial solution before entering every poultry house. This measure does not account for the fact that Salmonella Enteritidis can be transmitted through airborne routes.  
 
2.      You failed to prevent wild birds, cats, and other animals from entering poultry houses, as required by 21 CFR 118.4(b)(4). Specifically, our investigators observed wild birds, cats, or other animals in the poultry houses at the following locations:
  • 87-550 Kaukama Road (observed on September 13, 2011):
House (b)(4) - 2 wild birds
House (b)(4)  – 5 wild birds and 1 cat
House (b)(4)  – 3 wild birds
  • 87-730 Kaukama Road (observed on September 14, 2011):
House (b)(4) – approximately 20 wild birds
House (b)(4) – approximately 50 wild birds
House (b)(4) – approximately 25 wild birds
House (b)(4) – approximately 50 wild birds
  • 87-897 Apuupuu Road (observed on September 13, 2011):
House (b)(4) – approximately 200 wild birds
House (b)(4) – approximately 50 wild birds; 1 mongoose was also observed entering a hole in the building foundation
House (b)(4) – approximately 20 wild birds
House (b)(4) – approximately 10 wild birds
  • 87-925 Paakea Road (observed on September 12, 2011):
House (b)(4) – approximately 30 wild birds
House (b)(4) – approximately 200 wild birds
House (b)(4) – approximately 50 wild birds
House (b)(4) – approximately 100 wild birds
House (b)(4) – approximately 100 wild birds
 
In addition, our investigators observed numerous gaps in many of your poultry houses that could allow entry of stray animals and wild birds into the houses; many of these gaps were larger than one foot in diameter. 
 
Your undated written response, received October 7, 2011, states you intend to install a smaller mesh size poultry netting and additional welded wire on your layer houses. In addition, you state that 600 feet of new poultry netting has been received and repairs to the buildings will be addressed based on the availability of the materials and cash flow. FDA will verify your structural corrections during the next inspection.
 
3.     You failed to remove vegetation and debris outside a poultry house that may provide harborage for pests, as required by 21 CFR 118.4(c)(3). Specifically, our investigators observed grass vegetation, as high as 3 feet, in contact with poultry houses at the following locations:
    • 87-550 Kaukama Road – houses (b)(4), (b)(4), (b)(4) and (b)(4)
    • 87-730 Kaukama Road – houses (b)(4), (b)(4), (b)(4), and (b)(4)
    • 87-897 Apuupuu Road – houses (b)(4), (b)(4), (b)(4), and (b)(4)
    • 87-925 Paakea Road – houses (b)(4), (b)(4), (b)(4), (b)(4), and (b)(4)
Your undated written response, received October 7, 2011, states you will continue weed control on a daily to weekly basis and will improve your monitoring of each location. FDA will verify your correction during the next inspection.
 
4.      You failed to implement appropriate rodent monitoring methods. Specifically, during our inspection you only conducted visual monitoring of rodents and did not employ mechanical traps, glueboards, or another appropriate monitoring method, as required by 21 CFR 118.4(c)(1). Relying solely on visual inspection does not allow you to trend or enumerate the level of rodents within the facility. In addition, adequate rodent monitoring activities and accurate maintenance of rodent control monitoring records are key elements in assuring adequate rodent control at your egg laying facility.
 
Your undated written response, received October 7, 2011, included updated SE Prevention Plans with updated procedures for rodent monitoring, including both visual monitoring and mechanical trapping of rodents; however, you did not include monitoring records as evidence of your implementation.  Please refer to item number one, above, for the agency’s concern regarding missing details of how you will accomplish rodent control at your shell egg farms. FDA will verify your implementation of your rodent monitoring during the next inspection.
 
5.      Your environmental sampling plan is not appropriate to your poultry house layout, as required by 21 CFR 118.7(a). Specifically, your sampling scheme does not account for sampling of all manure piles with a separate drag swab. The section titled “Layer” of your SE prevention plan describes (b)(4) drag swab being used (b)(4) per manure bank for (b)(4) cage rows. (The same procedure is described in your updated SE Prevention Plans.) A different drag swab should be used for each manure bank to avoid saturation of the swab and potential masking of SE by other bacteria.
 
Please note that you are required under 21 CFR 118.8(a) to conduct testing to detect SE in environmental samples by the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses,” April 2008, or an equivalent method in accuracy, precision, and sensitivity in detecting SE. If you intend to use a sampling protocol other than that which is described in the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses,” we encourage you to submit additional documentation to FDA, so that we can determine if the sampling protocol you intend to use would allow for a testing methodology that is equivalent in accuracy, precision, and sensitivity in detecting SE.
 
The above violations are not meant to be an all-inclusive list of deficiencies 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 the responsibility to use procedures to prevent future violations of these statutes and regulations.
 
In addition to the above violations, we also have the following comments:
  • Your updated written SE Prevention Plans lack details to describe your firm’s cleaning and disinfection procedures in the event of an SE-positive environmental test,  such as the concentrations of the disinfectant(s) to be used and the manner in which cleaning and disinfection are to be carried out. These details help ensure that adequate procedures are followed every time a house requires cleaning and sanitizing. Presently your updated SE Prevention Plans only list that you will clean a house without providing details of the activities involved with complying, when applicable, with the cleaning and disinfection portion of the shell egg regulation. Additionally, please be aware that under 21 CFR 118.10(a)(3)(iii), you are required to keep a record of compliance with the cleaning and disinfection procedures performed at depopulation, when applicable.  
  • Your updated written SE Prevention Plans make no reference to many of the records that are required to be kept under 21 CFR 118.10. Please be aware that records are a critical component of any SE Prevention Plan and there are very specific requirements in 21 CFR 118.10(a)(3) regarding maintenance of records documenting compliance  with the SE prevention measures. Additionally, your updated SE Prevention Plans do not indicate how long your firm’s records are kept. Please see section 21 CFR 118.10(c) for the specific requirements regarding how long records must be maintained.
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 your rodent monitoring records and evidence that improvements to your layer barns have commenced. Your response to the FDA 483 indicates that you are unable to make corrections to your layer barns within 15 days, therefore your response should include a timeline within which 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 directed to Darlene Almogela, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, please contact Brandon L. Bridgman, Compliance Officer at 510-337-6794.
 
 
Sincerely,
/S/ 
Barbara J. Cassens
Director
San Francisco District
U.S. Food and Drug Administration
 
cc (via email): 
 
Lori K. Nagatoshi
Acting Program Manager
Food and Drug Branch
Hawaii Department of Health
lori.nagatoshi@doh.hawaii.gov