December 20, 2012
VIA UPS OVERNIGHT
WARNING LETTER CIN-13-357838-09
Midwest Poultry Services, LP
Robert L. Krouse, CEO
9951 State Road 25
Mentone, IN 46539
Dear Mr. Krouse:
From July 23 through July 25, 2012, the United States Food and Drug Administration (FDA) conducted an inspection of your shell egg production facility in Ft. Recovery, OH. We found that you have serious violations of 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 section 361(a) 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.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 can find the Act, the PHS Act, and the shell egg regulation at www.fda.gov
The significant violations are as follows:
1. Your firm failed to implement your SE Prevention Plan, as required by 21 CFR 118.4, and failed to use appropriate methods to achieve satisfactory rodent control when monitoring indicated unacceptable rodent activity within a poultry house, as required by 21 CFR 118.4(c)(1). Specifically, your firm's SE Prevention Plan, dated 01/11/2012, states if attention is needed in addressing spikes in rodent catches, a documented corrective action will be taken, and may be done in the form of notes on catch records or Corrective Action form 292-1-1. However, each of your four layer houses had rodent indexes of 3 (high), and your firm was unable to provide any documentation of corrective actions taken to address this level of rodent activity. In layer house 1 our investigators observed apparent rodent excreta pellets too numerous to count along the inside perimeter floor and walkway. In layer house 3 the rodent index was 3 eleven consecutive times and up to 113 rodents were caught in a 5 day period. Your firm's response dated August 6, 2012, is inadequate because you failed to provide an updated SE Prevention Plan that includes your new rodent monitoring procedures and documentation as indicated in your response. We will verify these corrections during our next establishment inspection.
2. Your firm failed to implement your SE Prevention Plan, as required by 21 CFR 118.4, and failed to maintain records documenting compliance with refrigeration requirements, as required by 21 CFR 118.1 O(a)(3)(iv). Your plan indicates that you will maintain records documenting that eggs grown at your layer site are refrigerated within 36 hours of lay on form# 290-1-1 for inline and form # 230-1-1 for off line. However, you did not maintain any records indicating your eggs are refrigerated within 36 hours of lay. Your firm's response dated, August 6, 2012, includes an updated copy of your "Finished Goods Inventory" form that contains a field for personnel to ensure that eggs are refrigerated each day; however, you did not include any completed forms to show you are implementing this change. We will verify your corrective actions during our next establishment inspection.
This letter may not list all of your firm's deviations. You are responsible for ensuring that your firm operates in compliance with the Act and all regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
In addition to the above violations, we also have the following comment:
• Although your SE Prevention Plan addresses cross contamination when people and equipment move between houses as required by 21 CFR 118.4 (b)(2) and (3), your plan does not mention keeping records documenting compliance with these measures. Please be aware that records documenting compliance with these measure are required under 21 CFR 118.10(a)(3)(i). Examples of relevant records are foot bath maintenance logs and logs indicating when disposable protective clothing was worn.
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 violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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.
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).
Your written response 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