Inspections, Compliance, Enforcement, and Criminal Investigations

Sixdog Investments, LLC 11/03/14

  

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

Public Health Service
Food and Drug Administration
 Denver District Office
Building 20-Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
TELEPHONE: 303-236-3000 

 

November 3, 2014


 

WARNING LETTER
 
VIA UPS Overnight
 
Nicolas J. DiGiorgio, Jr., Owner
Six Dog Investments, LLC (DBA Sixdog Farms)
12155 N County Road 15
Wellington, CO 80549
Ref: DEN-15-03-WL
Dear Mr. DiGiorgio:
 
The U.S. Food and Drug Administration (FDA) inspected your shell egg production facility, Sixdog Farms, located at 12155 N. County Road 15, Wellington, CO, on April 28 through May 29, 2014. 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. Our investigators' observations were noted on Form FDA 483, Inspectional Observations, issued to Mr. Joshua B. Hall, Chief of Operations, on May 29, 2014. 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.
 
Your significant violations are as follows:
 
1)    You failed to implement your SE prevention plan, as required by 21 CFR 118.4, and failed to maintain records documenting that pullets were SE monitored, as required by 21 CFR 118.10(a)(2). Specifically, the “Purchase of Chicks, Pullets, and Spent Hens: Required Documents” section of your SE prevention plan requires that the source of pullets and spent hens must provide documentation that pullets and spent hens are raised in SE-monitored conditions, and the source must have an SE-monitoring and prevention plan. However, you did not have documentation that pullets purchased from (b)(4), and chicks purchased from (b)(4), were procured from SE monitored[1] breeder flocks.  
 
2)     You failed to raise pullets under SE monitored conditions, including environmental testing, as required by 21 CFR 118.4(a).  Specifically, you did not conduct environmental testing at 14 to 16 weeks of age for chicks purchased from (b)(4), which are part of your (b)(4) flock (b)(4).    
 
3)     You failed to conduct environmental testing in a poultry house when any group of laying hens constituting the flock within the poultry house were 40 to 45 weeks of age, as required by 21 CFR 118.5(a).Specifically, the “SE Testing: Age Requirement” section of your SE prevention plan states that any chicks or pullets purchased and raised by your firm are required to have SE environmental testing conducted after reaching 40-45 weeks of age. However, you did not conduct environmental testing at 40 to 45 weeks of age for hens purchased from (b)(4), which are part of your (b)(4) flock.   
 
4)     You failed to implement your SE prevention plan, as required by 21 CFR 118.4, and failed to clean and disinfect your poultry house by appropriate procedures before new laying hens were added to the house when there was 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, your plan, in the “Sanitation for Flock Rotations and New Flocks” section, states that the poultry house is to remain vacant for a period of (b)(4)  after sanitation and disinfection takes place.  However, on April 28, 2014, you placed new hens in your (b)(4) barns less than (b)(4) after you depopulated these barns (b)(4) because of positive salmonella test results.
 
Further, you did not clean and disinfect your (b)(4) barn and (b)(4) barn by appropriate procedures before new laying hens were added. Specifically, your plan states that (b)(4). However, for disinfection your firm utilized a solution of (b)(4), which is lower than the concentration provided in your SE plan and not an appropriate disinfection method under 21 CFR 118.4(d)((3). 
 
In addition, you did not maintain records documenting compliance with cleaning and disinfection procedures performed at depopulation on 4/20/14, as required by 21 CFR 118.10(a)(3)(iii).
 
5)     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, the “Pest Control Program” section of your plan states that “fly strips shall be implemented around the interior of poultry facilities on an as needed basis (b)(4). Fly strips shall be checked and replaced on a (b)(4) or as needed basis . . .” 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. See http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocuments RegulatoryInformation/Eggs/ucm285101.htm.
 
6)     You failed to have and implement an SE prevention plan that includes an appropriate monitoring method for rodents, as required by 21 CFR 118.4(c)(1).Specifically, 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 an unacceptable level of rodent activity. 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/GuidanceDocuments RegulatoryInformation/Eggs/ucm285101.htm.
 
Further, you did not maintain records documenting compliance with rodent and other pest control measures, as required by 21 CFR 118.10(a)(3)(ii). Specifically, your firm did not maintain any pest control records for your (b)(4) barn, (b)(4) barn, (b)(4), and (b)(4) barn, where egg laying poultry for the (b)(4) are housed.
 
7)     You failed to implement your SE prevention plan, as required by 21 CFR 118.4, and failed 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, your plan states that all poultry housing facilities shall be furnished with proper and adequate exclusionary installments, such as netting over windows, blocking or patching of any holes or tears in walls, and properly sealing doors and ports. However, pests, bird nesting, and potential harborage areas were observed by our investigators in the (b)(4) barn, (b)(4) barn, (b)(4), and (b)(4) barn. Specifically,
  • A live bird was observed flying into the (b)(4) barn and settling in a nest perched on a wooden support beam. 
  • A live mouse-like rodent was observed entering in and out of two holes immediately outside the (b)(4) barn's main entrance. 
  • Bird nests were observed inside the (b)(4) barn and (b)(4) barn.
  • A bird nest was observed in your (b)(4) barn in an area where you house pullets.
 
8)     You failed to implement your SE prevention plan, as required by 21 CFR 118.4, and  failed to hold and transport eggs at or below 45 degrees Fahrenheit ambient temperature beginning 36 hours after time of lay, as required by 21 CFR 118.4(e). Specifically, your SE prevention plan states that all eggs shall be transported to cold storage refrigeration within 36 hours after the time of lay, and refrigerated egg storage shall be kept at an ambient temperature of 45 degrees Fahrenheit or below at all times. However, your procedure for “loose eggs” (b)(4) does not ensure the eggs are refrigerated at or below 45 degrees Fahrenheit within 36 hours from the time of lay.  Under your procedure, loose eggs may be (b)(4) without refrigeration for longer than 36 hours (b)(4).
 
9)     You failed to have adequate biosecurity measures, and/or to implement the “Biosecurity Program” section of your SE prevention plan, to ensure that there is no introduction or transfer of SE into or among poultry houses, as required by 21 CFR 118.4(b):
 
A.    You failed to prevent stray poultry, wild birds, cats, and other stray animals from entering the poultry houses, as required by 21 CFR 118.4(b)(4). Specifically, the hens in your (b)(4) barns, and (b)(4) shed were not restricted to their designated houses and pastures. Also, some of these hens were in close proximity with no barriers to other farm animals and domestic animals including (b)(4). In addition, the “Biosecurity Program” section of your SE prevention plan does not address this requirement.
 
B.    You failed to implement the “Personnel and Equipment Practices/Restrictions” section of your SE prevention plan, as required by 21 CFR 118.4, and you failed to maintain practices that will protect against cross-contamination when equipment or persons move between poultry houses, as required by 118.4(b)(2) and 118.4(b)(3). Specifically, your plan states that equipment used in all poultry facilities shall be cleaned, sanitized, and rinsed before being brought into another housing facility. However, the (b)(4) is not cleaned between use at each separate poultry house or farm. This (b)(4) was also noted to be used to transport (b)(4). Also, equipment such as containers used to (b)(4) are used (b)(4), and are not washed between use at each separate poultry house or farm. 
 
In addition, your SE prevention plan states that (b)(4) in order to compartmentalize facilities and reduce the likelihood of contamination between houses.  Your plan also states that employees will (b)(4). However, employees at your firm who move from one poultry house to another (b)(4). Further, your employees travel between this location and (b)(4), in their same street clothes and shoes.
 
C.   You failed to implement your SE prevention plan, as required by 21 CFR 118.4, and you failed to limit visitors on the farm and in the poultry houses, as required by 21 CFR 118.4(b)(1). Specifically, your plan states that visitors must sign in and out on the visitor sign-in sheet and be issued a visitor badge before entering company property and buildings; however, you did not ask investigators to sign a visitor log upon arrival at the start of the inspection on 4/28/14, and on 4/29/14, you were unable to provide a visitor log to our investigators, indicating that you had no method of tracking visitors via a visitor log.
 
Your plan also states all visitors must be accompanied by authorized personnel while on company property; however you did not implement this procedure. For example, on 5/5/14, a sign was observed at your (b)(4) which stated “(b)(4).” There were no instructions for these visitors to check-in, and these signs are insufficient to limit the whereabouts of visitors on your farm.
 
D.   You failed to have an SE prevention plan that ensures that employees do not keep birds at home, as required by 21 CFR 118.4(b)(5). Specifically, this requirement is not addressed in your written SE prevention plan.
 
10)   You did not maintain records regarding your SE prevention plan in accordance with the requirements set forth by 21 CFR 118.10(a). Specifically:
 
A.    You do not maintain records documenting compliance with refrigeration requirements, as required by 21 CFR 118.10(a)(3)(iv). Specifically, you do not keep temperature monitoring records for the refrigerated area used to store shell eggs sold to (b)(4), nor were any records provided to demonstrate that the temperature measuring device in the refrigerated storage area was calibrated. In addition, your firm does not have temperature monitoring or calibration records for your refrigerated truck used to transport eggs for distribution.
 
B.    Your SE prevention plan does not list your name and the location of your farm, as required by 21 CFR 118.10(b)(1). 
 
C.   Your SE prevention plan is not dated and does not carry the signatures of the person(s) who administers the plan, as required by 21 CFR 118.10(b)(3).
 
Insanitary Conditions and Practices:
 
Your eggs  were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health within the meaning of Section 402(a)(4) of the FD&C Act. Specifically, our investigators observed the following conditions and practices at your firm during the processing of shell eggs:
 
A.    Plastic egg flats, used to collect eggs and hold eggs for rinsing, were observed to be chipped, cracked, broken, and soiled with apparent manure. These egg flats were not cleaned between use in different poultry houses or farms. These conditions allow for the entrapment of filth and pathogens that may contaminate shell eggs being held in soiled plastic flats.
 
B.    Packaged eggs were observed staged on a table within three feet of a table holding eggs soiled with apparent manure. An employee was using a hose under pressure to spray water to rinse the visible manure off the soiled eggs. The water was observed splashing onto the table, and wall behind it, where packaged eggs were staged. These conditions may lead to contamination of packaged shell eggs with manure and/or other filth.
 
C.   An employee was observed using a white plastic scrub brush to remove visible apparent manure from collected eggs. The scrub brush was not cleaned and sanitized when used to clean eggs from different houses or at (b)(4). Harmful microorganisms may remain viable on improperly cleaned and sanitized utensils, and these items may lead to contamination of the food with which they come in contact.
  
D.   An employee was observed using a soiled cloth towel to wipe down food contact tables. The employee proceeded to handle eggs ready for packing, without changing their gloves and washing their hands. Harmful microorganisms may remain viable on improperly cleaned and sanitized food contact surfaces, and these items may lead to contamination of the food with which they come in contact. Additionally, human pathogens such as Salmonella, Hepatitis A, and Shigella spp. may be transmitted to foods by unwashed hands.
 
E.    You reuse cardboard flats, used to stage eggs ready for packing. Cardboard flats were observed soiled with what appeared to be egg yolk, egg shells, and feces. The flats are stacked on top of each other such that the bottoms of the flats come in direct contact with eggs ready for packing, and with other flats. These conditions may lead to cross-contamination of shell eggs stored in the flats.
 
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 operations are 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 future violations of these statutes and regulations.   
 
Your firm should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice, such as seizure, injunction, or initiation of administrative enforcement procedures under 21 CFR 118.12(a).  
 
In addition to the above violations, we also have the following comment:
  
The “Procedures in the Event of a Single Positive Test Result” section of your written SE prevention plan state that “egg tests are to be conducted (b)(4).” Please note that 21 CFR 118.6(c) requires four egg tests at 2-week intervals.
 
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (including any systemic corrections) that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  You should include in your response a revised written SE plan and other documentation or information which would assist us in evaluating your corrections. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the timeframe within which these activities will be completed. Your firm’s response should be comprehensive and address all violations cited in this Warning Letter.
 
Your firm’s response should be sent to: Denver District Office, 6th & Kipling Street, PO BOX 25087, Denver, CO 80225 (Attn: Nancy Schmidt, Compliance Officer). If you have any questions about the contents of this letter, please contact: Ms. Schmidt at 303-236-3046 (phone) or 303-236-3551 (fax).
 
 
Sincerely,
/S/
LaTonya M. Mitchell
District Director


[1]“SE” monitored means the pullets were raised under SE control conditions, including procuring chicks from SE-monitored breeder flocks that meet the National Poultry Improvement Plan’s standards for “U.S. S. Enteritidis Clean” status or equivalent standard, and testing the pullet environment for SE when pullets are 14 to 16 weeks of age, as required by 21 CFR 118.4(a)(1) and 118.4(a)(2)(i).

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