Inspections, Compliance, Enforcement, and Criminal Investigations
Trillium Farms LLC 11/29/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
November 29, 2012
VIA UPS OVERNIGHT
RETURN RECEIPT REQUESTED
WARNING LETTER CIN-13-355598-05
James R. Dean, CEO
James T. Dean, COO
Trillium Farms, LLC
10513 Croton Road
Johnstown, OH 43031
Dear Messrs. Dean:
The U.S. Food and Drug Administration (FDA)inspected your shell egg production facilities located at 11995 Croton Rd, Croton, Ohio (layer site 1); 11492 Wesley Chapel Rd, Croton, Ohio (layer site 4); 20449 County Rd 245, Mt. Victory, Ohio (layer site 5); 20613 Township Highway 103, Harpster, Ohio (layer site 6); and your headquarters office in Johnstown, Ohio, on June 27-July 12, 2012. We found that your facilities have 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). The failure to adequately implement the requirements in 21 CFR 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act, (the "PHS Act"), Title 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 "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 investigator’s observations were presented to you on form FDA-483, Inspectional Observations, at the conclusion of our inspection on July 12, 2012. You can find the Act, the PHS Act, and the shell egg regulation through links on FDA’s home pageat www.fda.gov.
The significant violations are as follows:
1. Your firm induced molt in a flock but then failed to perform environmental testing for SE in the poultry house at four to six weeks after the end of the molting process as required by 21 CFR 118.5(b). According to your record “Layers – after molt,” you define the end of molting to have occurred when the layers are returned to full feed. Your testing records document that the following testing occurred outside of the required four to six week time frame:
- Layer site 1 house 12 returned to full feed on 1/23/2012 and the environmental sample was collected on 3/30/2012, 9 weeks 4 days after the end of the molt.
- Layer site 4 house 52 returned to full feed on 12/30/2011 and the environmental sample was collected on 4/03/2012, 13 weeks 4 days after the end of the molt.
- Layer site 5 house 10 returned to full feed on 1/30/2012 and the environmental sample was collected on 3/27/2012, 8 weeks 1 day after the end of the molt.
- Layer site 5 house 11 returned to full feed on 12/05/2011 and the environmental sample was collected on 1/26/2012, 7 weeks 3 days after the end of the molt.
- Layer site 6 house 5 returned to full feed on 12/05/2011 and the environmental sample was collected on 1/25/2012, 7 weeks 2 days after the end of the molt.
- Layer site 6 house 2 returned to full feed on 1/13/2012 and the environmental sample was collected on 3/08/2012, 7 weeks 6 days after the end of the molt.
We have reviewed your response to the FDA-483 dated August 2, 2012. Your response included new internal notification procedures for molting timeframes. However, you did not address how and when your firm will initiate collection of the environmental samples. We will evaluate the adequacy of any proposed corrective action during our next inspection of your farms.
2. Your firm failed to monitor for rodents by appropriate methods as required by 21 CFR 118.4(c)(1). According to your firm’s Biosecurity Plan (dated 5-11-12), your rodent monitoring procedure at layer sites 1, 4, 5, and 6 is to count the number of rodents caught in metal un-baited catch traps weekly and divide that number by the number of catch traps to calculate your rodent index for the house. Your plan stated that a rodent index of 1 is “low,” 2 “moderate,” and 3 “high”; the plan stated that a rodent index of “greater than 1” should prompt corrective actions. However, your plan failed to define the number of rodents that correspond to the “low,” “moderate,” and “high” rodent index classifications. As a result, we are unable to determine whether your monitoring method indicates unacceptable rodent activity. Your procedure also is not specific about the number of catch traps to be placed; our investigator found that the number of traps that you set varies, to include 13 catch traps at layer sites 1 and 4 and 21 catch traps at layer sites 5 and 6. Because your rodent monitoring formula does not adjust for the varying number of catch traps that you use, it may not consistently indicate unacceptable rodent activity.
We have reviewed your response to the FDA-483 dated August 2, 2012. You indicated that you changed your rodent monitoring formula to be consistent with the formula as recommended in FDA’s December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” and that you are working with an entomologist consultant to consider the use of baited live capture traps. Although you stated that you will implement the formula for rodent indexing as outlined in FDA’s Guidance for Industry, your response does not address which threshold will initiate corrective actions. We recommend in FDA’s guidance that a rodent index of 1 or less is likely to indicate satisfactory rodent control. The guidance further recommends that if a rodent index greater than 1 is obtained, the producer should investigate to find out where rodents are entering the house. Additionally, your response does not indicate how many traps are to be placed per house nor the location of those traps within the house.
We cannot evaluate the adequacy of your corrective actions at this time because you failed to include a revised Biosecurity Plan with your response and you have not provided a definitive plan for monitoring rodent activity using the new rodent monitoring formula you have selected. We will evaluate the adequacy of any proposed corrective action during our next inspection of your farms.
3. Your firm failed to maintain records documenting compliance with refrigeration requirements, as required by 21 CFR 118.10(a)(3)(iv). Your production reconciliation records did not include the time at which eggs were put in the cooler. As a result, your records failed to document that any of your eggs were held and transported at or below 45 degrees ambient temperature beginning 36 hours after time of lay, as required by 21 CFR 118.4(e). In addition, we note that certain white shell eggs grown at layer site 6 on March 10, 2012 were not refrigerated within 36 hours after time of lay. These eggs were last collected at 1:30 AM on March 11. Layer site 6 did not have a cooler. An unrefrigerated truck picked up 720 cases of these eggs and delivered them to layer site 5 on March 12. Unloading of this truck did not begin until 3:40 PM on March 12. At 3:40 PM more than 38 hours had elapsed since the last white eggs were collected at layer site 6. These eggs were processed at and shipped from layer site 5 for the table egg market according to the layer site 6 plant manager, who worked at both layer sites 5 and 6.
We have reviewed your response to the FDA-483 dated August 2, 2012. We acknowledge that you created a record, entitled “Eggs to Cooler,” that includes the time when the last eggs collected for the day enter the cooler to meet the 36 hour refrigeration requirement. You also indicated that you have revised your SE Prevention Plans for all of your layer sites to include additional procedures for the refrigeration of eggs if one layer site needs to farm pack eggs to ship to another layer site. We will evaluate your firm’s revised SE Prevention Plans and verify your implementation of these new records during our next inspection of your farms.
4. Your firm failed to include the time of the activities reflected in your records, as required by 21 CFR 118.10(b)(2). Specifically, your “Weekly Rodent Bait Station Inspection Checklist” records documenting compliance with rodent control measures for layer sites 1, 4, 5, and 6 did not include the time the activity occurred. In addition, your firm’s records must include the name and location of your farm as required by 21 CFR 118.10(b)(1). However, your “Weekly Rodent Bait Station Inspection Checklist” records did not include your firm’s name.
We have reviewed your response to the FDA-483 dated August 2, 2012. You indicated that you have corrected all records; however, you did not attach a revised version of your “Weekly Rodent Bait Station Inspection Checklist” record to your response. We will evaluate the adequacy of any proposed corrective action during our next inspection of your farms.
This letter is not intended to be an all-inclusive list of your firm's violations. You are responsible for ensuring that your shell egg production facility operates in compliance with all applicable statutes and regulations, including the 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.
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).
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations noted above and to ensure that similar violations do not occur. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation, including your revised Biosecurity Plan and “Weekly Rodent Bait Station Inspection Checklist” record. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections.
Your written response to this letter should be sent to Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Mr. Rabe at 513-679-2700 ext. 2163.
Paul J. Teitell