- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameBradley E. Barga
- Judge Farms Inc
5636 Demming Road
Ansonia, OH 45303
- Issuing Office:
- Division of Human and Animal Food Operations East V
6751 Steger Drive
Cincinnati, OH 45237-3097
May 17, 2019
WARNING LETTER 569128
UNITED PARCEL SERVICE
Delivery Signature Requested
Bradley E. Barga, President
Judge Farms, Inc.
5636 Demming Road
Ansonia, Ohio 45303
Dear Mr. Barga:
On October 15-23, 2018, the U.S. Food and Drug Administration (FDA) inspected your shell egg farm, located at 5636 Demming Road, Ansonia, Ohio. During the inspection, the investigators observed 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 United States Code (USC) 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 USC 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 the FDA 483, Inspectional Observations, which was issued to you on October 23, 2018. You may find the FD&C Act, the PHS Act, and the shell egg regulation through links in FDA’s home page at www.fda.gov.
We acknowledge receipt of your response dated December 12, 2018 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 farm failed to have a written Salmonella Enteritidis prevention plan (SE Plan) with regard to procurement of pullets, as required by 21 CFR 118.4(a). Specifically, your written SE Plan failed to include the following required SE prevention measures:
a. Your SE Plan did not state that chicks will be procured from SE monitored breeder flocks that meet the National Poultry Improvement Plan’s standards for “US S. Enteritidis Clean” status or equivalent.
b. Your SE Plan did not state that the pullet environment will be tested for SE when pullets are 14 to 16 weeks of age or detail corrective actions to take if environmental testing results are positive.
We acknowledge in your response received December 12, 2018, that you have included statements in your “BEST MANAGEMENT PRACTICES SALMONELLA ENTERITIDIS PREVENTION PLAN LAYER MANAGEMENT” document regarding the procurement of chicks from an SE monitored facility and that the pullet environment is being tested when the pullets are 14-16 weeks of age. We will evaluate your implementation and level of compliance related to this corrective action during the next inspection.
2. Your farm failed to properly implement the biosecurity portion of your SE prevention plan in that you did not properly maintain the footbath, potentially rendering it ineffective at preventing the introduction of SE into your poultry house as required by 21 CFR 118.4(b). Specifically, your firm’s “BEST MANAGEMENT PRACTICES SALMONELLA ENTERITIDIS PREVENTION PLAN LAYER MANAGEMENT” document states as part of your biosecurity procedures that all visitors must enter through the packing room door and must use the foot bath before entering the packing room. This is also the entrance employees use to enter the layer house. During the inspection, you stated that you use (b)(4) of (b)(4) per (b)(4) for your footbath and that you change the solution approximately (b)(4). However, the (b)(4) bottle instructions state to use one-half ounce per gallon of water and allow the solution to come in contact with the boot/shoe for 10 minutes. The instructions also state to change the disinfecting solution when the solution becomes visibly dirty. Investigators observed that employees/visitors were not allowing their boots to stay in contact with the solution for 10 minutes and the solution appeared visibly dirty.
We acknowledge in your response received December 12, 2018 that your Layer Management BMP’s [Best Management Practices] Corrective Action Plan provides a footbath log that indicates that the footbath was cleaned on October 26, 2018. You also stated that you (b)(4). However, we are unable to evaluate the adequacy of your response because there was no long-term cleaning plan outlined in your SE plan and no documentation that you are following the instructions for your new cleaning solution. We will evaluate your implementation and level of compliance related to this corrective action during the next inspection.
3. Your farm failed to use appropriate methods to achieve satisfactory rodent control when your monitoring method indicated unacceptable rodent activity within a poultry house as required by 21 CFR 118.4(c)(1). Specifically, your firm’s “BEST MANAGEMENT PRACTICES SALMONELLA ENTERITIDIS PREVENTION PLAN LAYER MANAGEMENT” document states rodent monitoring will be performed on a (b)(4) basis. Your firm had (b)(4) inside the poultry house and you established a rodent index as a means to measure the effectiveness of your rodent control. Your firm’s goal was to maintain (b)(4) mice per (b)(4) caught in the (b)(4); however, your rodent monitoring procedures do not detail what appropriate corrective actions are to be taken when rodent activity is deemed to be unacceptable. A review of your firm’s rodent control monitoring records for the weeks of 09/10-16/2017, 09/02-08/2018, 09/09-15/2018, 09/16-22/2018, 09/23-29/2018, 09/30/2018-10/06/2018, and 10/07-13/2018, found you recorded 10 or more rodents in the traps, but no corrective actions were documented. Furthermore, investigators observed numerous rodents in your layer house during the inspection including: rodents of all life stages in the manure pit area (young, mature, and deceased); a live rodent on the egg belt touching an egg; eight live rodents on the walkways of rows four and five in the hen level; and a bucket of deceased rodents in the manure pit.
In addition, Investigators observed the following entry points whereby potential SE carrying pests may enter and exit your poultry house:
- Two holes, approximately 3 inches by 3 inches along the south wall in the manure pit area.
- One hole, approximately 2 inches by 1/8th inch around a pipe extending through the east exterior wall in the manure pit area.
- Damage to the building causing multiples holes in the south wall of the manure pit area.
- An approximate 1/8th inch gap between the bay door and floor in the storage area.
- An approximate 1/8th inch gap between the exterior door and wall on the west end of the egg production facility.
We acknowledge in your response, received December 12, 2018, that you stated that you will fix the holes noted during the inspection. However, there was no documentation provided to indicate that these corrections have been scheduled or started. You also included a corrective action to “increase (b)(4) to help eliminate rodents. Added to the pit area.” However, it is unclear if this is a one-time corrective action or if this corrective action will be followed every time there is an increase in rodent activity. The efficacy of your corrective actions will be verified at the next inspection. In addition, we note that the number of rodent traps in your SE Plan was lowered from (b)(4). Based on our observations during the inspection, (b)(4) traps do not seem adequate to achieve satisfactory rodent control. FDA recommends using 12 rodent traps to calculate a rodent index. See Guidance for Industry, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation. https://www.fda.gov/media/82653/download.
4. Your farm failed to use appropriate methods to achieve satisfactory fly control when your monitoring method indicated unacceptable fly activity as required by 21 CFR 118.4(c)(2). Specifically, your firm’s “BEST MANAGEMENT PRACTICES SALMONELLA ENTERITIDIS PREVENTION PLAN LAYER MANAGEMENT” document states fly control will be monitored using (b)(4) inch index cards hung in locations throughout the building and the cards will be checked (b)(4). (b)(4). Corrective actions outlined under “FLY CONTROL” state if the count on the cards is close to (b)(4), your firm will (b)(4), and if the count on the cards is over (b)(4), your firm will (b)(4). A review of your fly control records for the (b)(4), found your average for the index cards was above (b)(4) and under the “means/ways to reduce fly population” you listed “(b)(4)” as your corrective action. We understood this to mean that you (b)(4). The continued exceeding of your established threshold indicates this corrective action is not effective. This is evidenced by our investigators’ observations of flying insects too numerous to count throughout the inspection in the manure pit and the hen area.
We acknowledge in your response received December 12, 2018, that your Layer Management BMP’s Corrective Action Plan states that you (b)(4) and added (b)(4). However, according to your (b)(4) Record for Rodent Control, Cooler Temperature and Fly Control Record dated (b)(4), your fly speck count was above your limit of (b)(4) (84), and there was no documentation that a corrective action was taken. The efficacy of your corrective actions will be verified at the next inspection.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including the FD&C Act, the PHS Act, and the shell egg regulation. 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).
Please respond to this office in writing within 15 working days from your receipt of this letter. In your response, identify the procedures you have taken or will take to completely correct the current violations and prevent similar ones. Please include an update and documentation of your corrective actions as noted above. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the timeframe in which you will complete the corrections. If you believe you have complied with federal law, include your reasoning and any supporting information for our consideration.
Please send your reply to Zada L. Giles, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Suite 500, Nashville, TN 37217. If you have questions regarding any issues in this letter, please contact Ms. Giles at (615) 366-7985 or Zada.Giles@fda.hhs.gov.
Steven B. Barber
Director, Division V
Office of Human and Animal Food Operations-East