Inspections, Compliance, Enforcement, and Criminal Investigations
Nature Pure LLC 5/27/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
May 27, 2011
VIA UPS OVERNIGHT
WARNING LETTER CIN-11-170434-17
Kurt Lausecker, President and Owner
Nature Pure LLC
26560 Stonns Rd.
West Mansfield, OH 43358-9662
Dear Mr. Lausecker:
On February 7 through 16, 2011, the United States Food and Drug Administration (FDA) conducted an inspection of your shell egg production facility located at 26560 Storms Rd., West Mansfield, OH 43358. During the inspection, FDA collected environmental swab samples at three of your four active egg layer houses. All three of the environmental samples taken by FDA were subsequently found positive for Salmonella Enteritidis (SE). After your firm was notified of the sample results, FDA conducted a follow-up inspection on February 28 through March 2, 2011. During both of our inspections, we found that your facility had 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 "FFD&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 can find the FFD&C Act, the PHS Act, and the shell egg regulation at www.fda.gov.
The significant violations were as follows:
1. You failed to maintain records documenting compliance with egg sampling procedures, as required under 21 CFR 118.10(a)(3)(v). Specifically, during our February 28th through March 2nd, 2011 inspection, a representative of your firm stated that the firm had sampled 1080 eggs from each of the egg layer houses for which an environmental sample had been found positive for SE. However, your firm did not have any records documenting that a minimum of 1,000 intact eggs representative of a day's production, from each SE positive house, were collected and delivered for testing. Specifically, none of your testing documentation or shipping documentation states that appropriate numbers of eggs from your layer houses were properly sampled.
2. You failed to test your pullet environment for SE when pullets were 14 to 16 weeks of age, as required under 21 CFR 118.4(a)(2)(i). Specifically, during the February 7 through 16, 2011 inspection, our inspector learned from your test records that pullets at Farm 1, pullet house 7, located at 26586 St. Rt. 739, Raymond, OH 43067, were not tested for SE between 14 to 16 weeks of age. The pullet house was sampled on 01/25/2011, when the pullets were approximately 12 weeks and two days of age. We acknowledge that, during our February 28 to March 2, 2011 inspection, we found that you had revised your SE plan to specify that pullet houses be tested within the correct age range.
3. Your written SE prevention plan lacks cleaning and disinfection procedures for use when an environmental test is positive for SE, as required under 21 CFR 118.4(d). Our investigator noted this on the FDA Form 483 that you were given at the close of the February 7 through 16, 2011 inspection. During our inspection of February 28 to March 2, 2011, we found that your SE plan still lacked a cleaning and disinfection procedure for use when an environmental test is positive for SE. Your written response dated March 10, 2011, stated that you were in the process of establishing such a procedure, and that you would have the procedure in place no later than April 15, 2011. FDA will verify this addition to your SE plan during the next inspection.
4. Your written SE prevention plan lacks an appropriate monitoring method for monitoring for flies, as required under 21 CFR 118.4(c)(2). The FDA Form 483 that you were given at the close of the February 7 through 16, 2011 inspection noted that your SE plan did not address fly monitoring. During our inspection of February 28 to March 2, 2011, we found that your SE plan still did not address this issue. Your written response dated March 10, 2011, stated that you were in the process of adding a fly monitoring program, and that you would have the program in place no later than April 15, 2011. FDA will verify this addition to your SE plan during the next inspection.
This letter is 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 FFD&C 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 legal action without further 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 also have the following comment. During our February 28 to March 2, 2011 inspection, the inspector explained to you that you need to use appropriate equipment for your environmental testing method. The proper use of sampling media and equipment, such as EZ sponges containing buffer, are essential in ensuring that you obtain accurate results from the environmental sampling conducted at your firm.
During our February 28 to March 2, 2011 inspection, we also discussed whether the (b)(4) method that you were using to detect SE in environmental samples was equivalent in accuracy, precision, and sensitivity to the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses," April 2008, as required by 21 CFR 118.8(a). In the Corrective Action Plan sent with your response dated March 10, 2011, you requested that FDA assess this question of equivalency. We have evaluated the information provided and cannot make an equivalency determination without data to support a side by side evaluation of the (b)(4) method and the method referenced in 21 CFR 118.8(a). We encourage you to submit additional documentation to FDA, so that we can determine if the (b)(4) method is equivalent in accuracy, precision, and sensitivity in detecting SE.
Within fifteen working days of receipt of this letter, you should notify this office in writing of the specific steps that you have taken or will take to correct the noted violations and to prevent their recurrence. Your response should include documentation of the corrective actions you have taken. 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 should be sent to Mark E. Parmon, 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. Parmon at 513-679-2700 ext. 2162.
Teresa C. Thompson