Inspections, Compliance, Enforcement, and Criminal Investigations
David C. Kauffman 11/13/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Kansas City District|
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100
November 13, 2013
RETURN RECEIPT REQUESTED
David C. Kauffman, Owner
David C. Kauffman
1860 500th St. SW
Kalona, IA 52247-9249
Dear Mr. Kauffman:
The U.S. Food and Drug Administration (FDA) inspected your shell egg production facility, David C. Kauffman, 1860 500th St. SW, Kalona, IA 52247-9249, on June 19-21, 2013. 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. Kauffman on June 21, 2013. You may find the FD&C Act, the PHS Act, and the shell egg regulation through links on FDA's home page at http://www.fda.gov.
Your significant violations are 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, your "Record Keeping Plan," which we evaluated as a written SE prevention plan, failed to include the following required SE prevention measures:
• Procurement of 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, as required by 21 CFR 118.4(a)(1);
• A requirement that the pullet environment be tested for SE when pullets are 14 to 16 weeks of age, as required by 21 CFR 118.4(a)(2). Specifically, your "Record Keeping Plan" states that pullet swabbing is conducted. However, your plan does not provide the details that are required under 21 CFR 118.4(a)(2). In addition, you were unable to provide records to show that the pullet environment was tested for SE when pullets were 14 to 16 weeks of age, as required by 21 CFR 118.10(a)(2);
• Practices that will protect against cross contamination when persons move between poultry houses, as required by 21 CFR 118.4(b)(3);
• Preventing stray poultry, wild birds, cats, and other animals from entering your poultry houses, as required by 21 CFR 118.4(b)(4);
• Not allowing employees to keep birds at home, as required by 21 CFR 118.4(b)(5);
• Removal of vegetation and debris outside of poultry houses that may provide harborage for pests, as required by 21 CFR 118.4(c)(3);
• Cleaning and disinfection procedures to be used before new laying hens are added to the house, if you have had 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).
We note that your written SE prevention plan lacks sufficient details in numerous areas, as indicated above, to ensure consistent implementation of adequate SE prevention measures at your farm. An additional example of this lack of detail in your written SE prevention plan is the failure to provide information on the placement of the "(b)(4)" traps, "fly control tape", or "spot cards" as part of your rodent and fly monitoring. Additionally, your plan does not include appropriate methods for achieving satisfactory rodent and fly control when monitoring indicates unacceptable rodent and fly activity, as required by 21 CFR 118.4(c)(1) and 21 CFR 118.4(c)(2), respectively. Further, your refrigeration control measure of "(b)(4) refrigeration log kept" in your plan does not address the requirement to hold and transport eggs at or below 45°F ambient temperature beginning 36 hours after time of lay, as required by 21 CFR 118.4(e).
2. You failed to implement your written SE prevention plan, as required by 21 CFR 118.4. Specifically, our investigators documented the following examples of failing to implement measures required by your "Record Keeping Plan":
• Your "Record Keeping Plan" states that your refrigeration log is kept (b)(4). However, review of your "Cooler Refrigeration Log Sheet" records indicated that refrigeration temperatures were not recorded on the following dates: December 1-4, 13, 15, 16, 18, 22, 2012; January 7, 12, 14-20, 22, 25-27, 2013; February 1-3, 7, 9, 13-15, 17, 22-24, 27, 2013; March 1, 3-4,6-9, 12, 19-20,24, 2013; April 1-3, 6-7, 9-10, 12, 14, 16,20-21,23,27-30, 2013; May 1-2, 7, 17-19,22-23,28-29,2013.
• Your "Record Keeping Plan" states "Fly control fly tape in egg room change (b)(4) spot cards in chicken house (corrective action) (b)(4) spots a (b)(4); sticky tape (hanging)." However, your "Fly Control Log Sheet" indicates that you monitor for flies (b)(4).
3. You failed to hold eggs at or below 45°F ambient temperature beginning 36 hours after time of lay, as required by 21 CFR 118.4(e). Specifically, your eggs are collected before (b)(4), hand carried to your cooler, and are picked up (b)(4) to be processed; therefore, eggs could be stored up to (b)(4) in your cooler. Your "Cooler Refrigeration Log Sheet" showed temperatures above the required 45°F for greater than 36 hours during the following timeframes since December 12, 2012:
• December 12, 2013, 7:30 pm - December 14, 2012, 7:22 pm (Temperature range recorded 47°F to 48°F)
• January 1, 2013 - January 11, 2013 (Temperature range recorded 46°F - 50°F)
• February 8, 2013, 7:10 pm - February 11,2013,7:20 pm (Temperature recorded 47°F)
• February 25, 2013 - March 2, 2013 (Temperature range recorded 47°F to 48°F)
• March 10, 2013 - March 21, 2013 (Temperature range recorded 46°F to 49°F)
4. You failed to maintain practices that will protect against cross contamination when equipment is moved among poultry houses, as required by 21 CFR 118.4(b)(2). Specifically, your skid loader is used to clean out manure from laying houses at your farm and at a separate farm location. You stated that you do not clean or disinfect the skid loader before using it, and that you do not know the SE status of the other farm or whether the operator of the other farm cleans the skid loader after using it. In addition, your SE prevention plan does not specify any biosecurity measures to prevent the introduction or transfer of SE into or among your poultry houses when equipment moves between locations as required by 21 CFR 118.4(b)(2).
5. You failed to maintain records documenting your rodent monitoring activities, as required by 21 CFR 118.10(a)(3)(ii). Your "Record Keeping Plan" states that "(b)(4) are used and checked (b)(4)." However, review of several of your "Rodent Monitoring Log Sheets" indicated no record that rodent monitoring was conducted on the following dates: August-October, 2012; December 2-9, 11-21, 23-28, 30-31, 2012; January 1-7, 9-31, 2013; February 1-13, 17-19, 22-28, 2013; March 1-4, 6, 10-12, 16-19, 24-31, 2013; April 1-3, 5, 8-11, 13-16, 18-22, 26, 28, 2013; May-June 20, 2013.
6. You failed to include your name and the location of your farm on all required records as required by 21 CFR 118.10(b)(1). Specifically, the following records do not identify your name and the location of your farm:
• Record Keeping Plan
• Fly Control Log Sheet
• Pest Control Product Use Log
• Rodent Monitoring Log Sheet
• Cooler Refrigeration Log Sheet
• Corrective Actions Log
7. You failed to include, as part of each record required by 21 CFR 118.10(a), the date and time of the activity that the record reflects, as required by 21 CFR 118.10(b)(2). Specifically, your "Rodent Monitoring Log Sheet" does not include the time the activity was performed, and your "Fly Control Log Sheet" and "Pest Control Product Use Log" do not include the date or time the activity was performed.
8. You failed to have a written SE prevention plan that bears a date and the signature(s) of the person(s) who administer the plan as required by 21 CFR 118.10(b)(3). Specifically, your "Record Keeping Plan" does not have the plan date or signature of the administrator.
The above violations are not intended to be an all-inclusive list of violations 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 PHS Act, the FD&C Act, and the shell egg regulation. You also have the responsibility to use procedures to prevent future 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).
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. You should include in your response a revised written SE prevention plan and other documentation or information which would assist us in evaluating your corrections. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed.
Your written response to this letter should be sent to Jessica E. Hensley, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 8050 Marshall St., Suite 205, Lenexa, Kansas 66214. If you have any questions about this letter, please contact Compliance Officer Jessica E. Hensley at 913-495-5183.
Dr. Ann Adams
Acting District Director
Kansas City District Office