Humpty Dumpty Eggs, Inc 11/15/11
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
November 15, 2011
RETURN RECEIPT REQUESTED Refer to MIN 12 - 06
Paul R. Brandt
President and Co-Owner
Mark A. Brandt
Vice President and Co-Owner
Humpty Dumpty Eggs, Inc.
1208 Humpty Dumpty Road
Reedsville, Wisconsin 54230
Dear Messrs. Brandt:
The Food and Drug Administration (FDA) inspected your shell egg production facility located at 1208 Humpty Dumpty Road, Reedsville, WI, on July 25-27, 2011. During the inspection FDA found that your facility had serious violations of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR 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 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 may find the Act, the PHS Act, and the shell egg regulation through links on FDA’s home page at www.fda.gov.
Your significant violations were as follows:
- Your firm does not have a written Salmonella Enteritidis (“SE”) prevention plan, as required under 21 CFR 118.4.
We acknowledge your letter dated August 3, 2011, sent in response to our inspection. In this letter you state that you will begin writing a comprehensive SE prevention plan. Because you did not include a completed plan, we were unable to evaluate the adequacy of this correction. Your SE prevention plan should address the remaining issues noted during our inspection, and should comply with all of the requirements for written SE prevention plans that are set forth in the shell egg regulation.
- You failed to implement appropriate rodent monitoring methods, as required by 21 CFR 118.4(c)(1). Specifically, you do not use an appropriate monitoring method that allows you to determine when there is unacceptable rodent activity within a poultry house. Additionally, during the inspection our investigators noted that mouse traps used by your firm are not located against the walls of the egg laying houses. Due to the nature of mouse behavior this placement of the traps reduces the possibility of a mouse entering the trap. Furthermore, in comparing your firm’s rodent bait and trap placement maps to the location of the bait and traps in the egg laying houses, our investigators noted that the number and location of the bait and mouse traps are not accurately reflected in your firm’s rodent control records. Adequate rodent monitoring activities and accurate maintenance of the rodent control monitoring records required under 21 CFR 118.10(a)(3)(ii) are key elements in assuring adequate rodent control at your egg laying facility.
We acknowledge your written response dated August 3, 2011, in which you state that you are currently monitoring and documenting rodent control. We were unable to assess the adequacy of this correction because you did not provide a copy of your written rodent control procedure or a description of how you monitor for rodents, how you determine if there is unacceptable rodent activity within a poultry house, and what methods you are prepared to use in the event of unacceptable rodent activity.
- You failed to perform environmental testing for SE when laying hens were 40 to 45 weeks of age, as required under 21 CFR 118.5(a). Specifically, at the time of the inspection the flock in Barn (b)(4) was 57 weeks of age and the flock in Barn (b)(4) was 76 weeks of age and no environmental testing had been conducted by your firm. You informed our investigators that no environmental testing has been performed by the firm since the compliance date of the shell egg regulation on July 9, 2010.
We acknowledge that your written response dated August 3, 2011, says that all flocks of birds that qualify for testing at 40-45 weeks old will be tested. FDA will verify this correction during the next inspection.
- You failed to maintain records documenting your SE prevention measures, as required under 21 CFR 118.10. Specifically:
- As indicated above, your firm does not have a written SE prevention plan as required by 21 CFR 118.4. Maintenance of such a plan is required under 21 CFR 118.10(a)(1). We acknowledge your written response on this matter, which is discussed above.
- You do not maintain records documenting compliance with biosecurity measures, as required under 21 CFR 118.10(a)(3)(i). We acknowledge your written response dated August 3, 2011, stating that you will keep additional records that document compliance regarding biosecurity. We will verify this correction at our next inspection.
- Between July 9, 2010, and January 30, 2011, your firm did not maintain records of rodent control measures, as required under 21 CFR 118.10(a)(3)(ii). We acknowledge that your firm is currently maintaining such records, though as is discussed above, FDA investigators found inaccuracies in these records.
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 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 respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you have done or plan to do to correct these violations and prevent their recurrence. You should include in your response documentation and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the time within which the remaining corrections will be completed.
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 send your reply to the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Wisecup at the number listed in this letter’s header.
Elizabeth A. Waltrip