| Public Health Service Food and Drug Administration |
Kansas City District Southwest Region 11630 West 80 Street Lenexa, Kansas 66214-3340 |
Department of Health and Human Services
October 15, 2010
SENT VIA UPS
WARNING LETTER
Ref. KAN 2011-01
Mr. Austin J. Decoster, Owner
Quality Egg LLC
2674 Highway 69
Galt, IA 50101
Dear Mr. Decoster:
In early July 2010, the U.S. Centers for Disease Control and Prevention (CDC) identified a nationwide increase in the number of Salmonella Enteritidis (SE) cases. Epidemiologic investigations conducted by public health officials in 10 states since April 2010 identified 26 restaurants or SE outbreak clusters where more than one ill person with the outbreak strain had eaten. Data from these investigations suggest that shell eggs were a likely source of infections in many of these restaurants or SE outbreak clusters. As you are aware, your firm has been implicated as one of the sources of SE-contaminated shell eggs.
On August 12 through 30, 2010, investigators from the United States Food and Drug Administration (FDA) inspected your feed mill and egg laying facilities located in Galt, Iowa; Clarion, Iowa; and Dows, Iowa. FDA laboratory analyses of environmental samples collected during this inspection found the presence of Salmonella Enteritidis in egg laying barns at Layer #2 and Layer #4 (Wright County Egg, Clarion, IA). In addition, FDA laboratory analyses of feed samples collected during this inspection found the presence of Salmonella Enteritidis in a feed ingredient, as well as finished feed, stored in your feed mill (Quality Egg LLC, Galt, IA).
In addition, our inspection found that your firm has serious deviations from the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (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 the Public Health Service Act, (the "PHS Act"), Title 42 U.S.C. Section 264(a). In addition, your shell eggs are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.A. 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 can find the Act, the PHS Act, and the shell egg regulation at www.fda.gov. The observations of concern to us are as follows:
• You must implement your SE Prevention Plan, to comply with 21 CFR 118.4. However, you failed to implement your "Quality Egg Bio-security Plan," ("plan") dated 8/11/10 as follows:
â–º Your plan states that you will (b)(4)(page 8, (b)(4). However, you failed to eliminate rodent hiding places and nesting sites as evidenced by the following observations at Layer 3:
• An approximately 2x6 inch wood board was observed on the ground at House 1.
• Unused wooden structures were observed located approximately 5 feet from the exterior of House 15.
• Grass approximately 12 inches high was observed between Houses 11 and 12.
â–º Your plan references (b)(4)(page 13, (b)(4)). However, you failed to properly seal all of your hen houses as evidenced by the following observations:
• Non-chicken feathers were observed inside Layer 3, House 3. One live wild bird was observed flying above chicken cages inside Layer 1, House 9. Wild birds were observed flying inside and outside of Layer 1, Houses 11 and 12. Pigeons were observed roosting in an air vent where the screen was damaged on the south side of Layer 1, House 14.
• The outside access doors to the manure pits had been pushed out by the weight of manure, leaving open access to wildlife and other animals at the following locations: Layer 1, House 1 and Layer 3, Houses 2, 17, 18.
• Exterior structural damage allowing entrance to the interior of the laying houses was observed at Layer 1, Houses 1,3,4, 7, 8, 11, 12; Layer 2, Houses 7 and 11; Layer 3, Houses 1, 2, 11, 13, 14, 15 and 18; Layer 4, House 3. Observations include holes in the exterior siding, missing siding, holes and/or gaps in the concrete foundation and air vent screens either missing or damaged.
• East and west doors located on the second floor egg laying areas of Layer 1, Houses 1 through 14; Layer 2, Houses 7 and 11; Layer 3, Houses 1,3,4,5,6,9,11,15,16,17, and 18; Layer 4, House 3 were observed to have gaps at the bottom and sides ranging from 1/2 inch to 2 inches.
â–º Your plan states that you will (b)(4) (page 7, (b)(4)). However, you failed to properly bait and seal rodent burrows located along the second floor baseboards inside Layer 1, Houses 1 through 9 and 11 through 13; Layer 2, Houses 7 and 11; Layer 3, Houses 1,3,4,5, and 6; and Layer 4, House 3.
â–º Your plan states that (b)(4)(page 12, (b)(4)). However, you failed to properly eliminate all sources of water in the manure pits as evidenced by the following observations:
• Dark liquid which appeared to be manure was observed seeping through the concrete foundation to the outside of the laying houses at Layer 1, Houses 1 through 5, 8, 11, 12, and 14; and Layer 3, Houses 1,8, 13, 17.
• Standing water approximately 3 inches deep was observed in the southeast comer of the manure pit located inside Layer 1, House 13.
• You must take biosecurity measures to ensure that there is no introduction or transfer of SE into or among poultry houses, to comply with 21 CFR 118.4(b). However, your firm failed to ensure that SE is not introduced or transferred into or among poultry houses as evidenced by the following observations:
â–º Not all egg laying houses had an entry door. Entrances for houses on Layer 1 and Layer 2 were located on even numbered houses. Entrances for houses on Layer 3 and Layer 4 were located on odd numbered houses. Therefore, to gain entry to a house without an entry door, employees had to enter from an adjoining house.
â–º Employees working within the houses did not change protective clothing when moving from house to house. For example, an employee at Layer 6, House 3 was observed walking out of House 3 with a metal scraper and into House 2 without changing protective clothing and without cleaning/sanitizing equipment between houses.
â–º Uncaged chickens were observed in the egg laying operation in contact with the egg laying birds at Layer 3, Houses 9 and 16. The uncaged birds were using the manure to access the egg laying areas.
â–º The entrance door to Layer 3, House 11 was blocked with excessive amounts of manure in the manure pits.
• You must use appropriate methods to achieve satisfactory rodent and pest control as required by 21 CFR 118.4(c). However, your failed to achieve satisfactory rodent and pest control as evidenced by the following observations:
â–º There were between 2 to 5 live mice observed inside the following egg laying houses: Layer 1, Houses 1,5, and 10; Layer 2, House 11; Layer 3, Houses 2, 5, 7, 9,11, and 14; and Layer 4, House 3.
â–º Live and dead flies too numerous to count were observed inside the following egg laying houses: Layer 1, Houses 3, 4, 6, 8, 9, 11, and 12; Layer 2, Houses 7 and 11; Layer 3, Houses 3, 4,5,6, 7, 8, 15, 16, 17, and 18. The flies were observed on and around egg belts, feed, shell eggs and walkways in different sections of each egg laying house. In addition, live and dead maggots too numerous to count were observed on the manure pit floor at Layer 2, House 7.
• You must maintain records documenting the implementation of your SE Prevention Plan, to comply with 21 CFR 118.10(a). However, your firm failed to document the monitoring of the following aspects of your SE Prevention Plan:
â–º Your plan states that you will (b)(4)(page 7, (b)(4)). However, you failed to document your inspections of rodent traps and bait stations at the following locations: Layer 1, Houses 1 through 14 had no records after July 15, 2010; Layer 2, House 1 and 2 had no records; and Layer 3, Houses 1 through 11 had no records after July 14, 2010 and Houses 12 through 18 had no records after July 15, 2010.
â–º Your plan states (b)(4)(page 5, (b)(4)). However, you did not document washing and disinfection of your dead hen truck prior to moving from farm to farm.
This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, the shell egg regulation, and the PHS Act. You also have a responsibility to use procedures to prevent further violations.
You should take prompt and aggressive actions to eliminate the Salmonella Enteritidis contamination and the observations described in this letter. Failure to take prompt corrective action may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure and/or injunction.
FDA is in receipt of your response dated October 5,2010, to the FDA-483 and additional information you submitted reflecting ongoing discussions with the agency of your corrective actions. We acknowledge your commitment to correcting the deviations and will verify your corrections via inspection.
Your reply to this Warning Letter should be sent to Danial Hutchison, Compliance Officer, Food & Drug Administration, 11630 West 80th Street, Lenexa, Kansas 66214-3340. If you have any questions about the content of this letter, please contact Mr. Hutchison at 913-752-2774.
Sincerely,
/S/
John W. Thorsky
District Director
Kansas City District
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