- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NameJudy M. Luoma
- Luoma Egg Ranch, Inc.
35705 State Highway 18
Finlayson, MN 55735-4277
- Issuing Office:
- Office of Human and Animal Foods - West Division 1
December 10, 2019
Refer to CMS 588099
Dear Ms. Luoma:
The United States Food and Drug Administration (FDA) inspected your shell egg farm located at 35705 State Highway 18, Finlayson, Minnesota, from June 18 - 21, 2019. The inspection revealed 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 Part 118). Failure to comply with the provisions of 21 CFR Part 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. You may find the FD&C Act, the PHS Act, and the Shell Egg regulation through links on FDA's homepage at www.fda.gov.
We received your written response dated June 30, 2019, concerning our investigators' observations noted on the Form FDA-483 (FDA-483), lnspectional Observations, which was issued on June 21, 2019, at the conclusion of our inspection. Our review reveals that your response is inadequate, as further explained in this letter. For additional information please see FDA's Guidance for Industry, "Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation," dated December 2011, www.fda.gov/media/82653/download.
The significant violations include, but are not limited to, the following:
1. Your firm failed to conduct environmental testing when a group of hens is 40-45 weeks of age, as required by 21 CFR 118.S(a). Specifically, page 30 in your "Salmonella Enteritidis Plan" (SE prevention plan) states that environmental testing must be conducted at 14 to 16 weeks and 40 to 45 weeks of age; however, you were not able to provide documentation indicating that environmental testing was conducted in poultry houses (b)(4) when the laying hens were 40 to 45 weeks of age.
Your response states that the requirement was misinterpreted, and that your veterinarian would visit the farm and retrain employees on correct SE sampling procedures. Your response did not include any documentation that the retraining occurred or provide the content of the training. Any retraining effort should include a review of required timepoints at which samples must be taken. Based on your response, we are unable to determine if this concern was addressed.
2. Your firm failed to hold your eggs intended to be used as table eggs at or below 45°F beginning 36 hours after the time of lay, as required by 21 CFR 118.4(e).
Specifically, our investigators observed:
• Unwashed shell eggs that were laid on June 3 and 5 - 7, 2019, and intended for distribution to the table market, held in the "(b)(4)'' at over 45°F on June 18 and 19, 2019; and
• Washed and packaged shell eggs that were laid on June 10, 12, and 14, 2019, held in the "(b)(4)" at temperatures over 45°F on June 18, 19, and 21, 2019.
Your response indicates that repairs were being made to (b)(4) during the inspection; however, it is unclear what repairs were made, and if the repairs would prevent a recurrence. In addition, you failed to address any corrective actions taken with regard to the eggs that were held at unrefrigerated temperatures.
3. Your firm failed to use appropriate monitoring methods to monitor for flies, as required by 21 CFR 118.4(c)(2). Specifically, your monitoring procedures involve (b)(4) within each poultry house. Your monitoring record from June 14, 2019, recorded "2," indicating that (b)(4) was detected within poultry houses (b)(4). In contrast to your observations, our investigators observed flies too numerous to count within poultry house (b)(4), in the "(b)(4)" egg collection area and egg (b)(4), and in stagnant water inside the "(b)(4)," indicating that your monitoring method is inadequate.
Furthermore, your SE prevention plan states that (b)(4) will be used to determine whether additional actions are taken; however, you do not record (b)(4) on your rodent monitoring records. Further, your plan does not provide a threshold level of unacceptable rodent activity within a poultry house. Without a threshold, such as (b)(4), it is impossible to determine an unacceptable level of rodent activity.
Your response includes a revised monitoring procedure that increases the locations monitored within a poultry house from (b)(4). However, you fail to address the size of the monitoring area that will be used. FDA's Guidance for lndustry, "Prevention of Salmonella Enteritidis in Shell Eggs during Production, Storage and Transportation," dated December 2011, recommends that the monitoring area be 0.8 square meters.
4. Your firm did not remove debris outside a poultry house that may provide harborage for pests, as required by 21 CFR 118.4(c)(3). Specifically, FDA investigators observed debris, including trash, stored inside the "(b)(4)."
Your response states that the "(b)(4)" was cleaned; however, your response does not address your storage of trash in the cooler.
In addition, further review of the documentation obtained during our inspection revealed the following deficiencies.
5. Your SE prevention plan did not include measures to properly maintain biosecurity practices to protect against cross-contamination when equipment and people are moved between poultry houses, as required by 21 CFR 118.4(b)(2) and (3). Specifically, your SE prevention plan states that "(b)(4)." However, you are required to always have measures in place to protect against cross-contamination regardless of a negative or positive environment.
6. Your firm failed to implement bioscurity practices to limit the number of visitors on the farm and in the poultry houses, as required by 21 CFR 118.4(b)(1). Specifically, although your SE prevention plan indicates that visitors will be restricted and will follow the farm's biosecurity practices, the FDA investigators observed multiple truck drivers and refrigeration repair personnel coming and going into the egg washing, egg packing, egg storage, and barn areas without following your biosecurity practices. In addition, your SE prevention plan lists a required down time of (b)(4) for visitors, while your "Visitor Sign In" sheet states that "Visitors must not have visited any egg processing facility for 24 hours prior to visit."
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the applicable statutes and regulations, including the FD&C Act, the PHS Act, and the Shell Egg regulation. You are also responsible for using procedures to prevent future violation 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 future notice, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).
In addition to the above violations, we have the following comments:
• Your SE plan should be specific to the houses that are on your farm. Currently your SE prevention plan includes a number of different house styles that are not present at your farm. You should refine your plan to include only the houses that are specific to this farm to avoid any confusion by employees implementing the SE prevention plan.
• Your "Egg Diversion Plan" states in part that you will divert eggs "[i]f the (b)(4)." Note that the required time period for testing is 14 to 16 weeks. See 21 CFR 118.4(a)(2).
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 15 working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days of receiving this letter, state the reason for the delay and the timeframe within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made. If you do not believe that your products are in violation of the statutory and regulatory requirements, include your reasoning and any supporting information for our consideration.
Please send your written response to Katherine L. Arnold, Compliance Officer, U.S. Food and Drug Administration, at 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota, 55401. If you have any questions regarding any issues in this letter, please contact Ms. Arnold at (612) 758-7159.
Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Food Operations