3. You failed to procure pullets that were SE monitored or raise pullets under SE monitored conditions, as required by 21 CFR 118.4(a). Specifically, documentation provided by the pullet grower shows that the pullet environment was tested when the pullets were 13 weeks of age. Under 21 CFR 118.4(a)(2)(i), the pullet environment should be tested when pullets are between 14 and 16 weeks of age.
4. You failed to conduct environmental testing for SE in the poultry flock 4 to 6 weeks after the end of the molting process as required by 21 CFR 118.5(b). While you could not provide documentation of when your flock’s molt ends, investigators noted that you describe the end of molt as the time when you stopped feeding the laying hens the molting ration, which was on May 31, 2017. You tested the laying house environment on July 26, 2017, which is more than 4 to 6 weeks after the date you define as the end of molt.
5. You failed to properly implement your SE prevention plan as required by 21 CFR 118.4. Specifically, you failed to properly implement the rodent and pest control measures outlined in Section Four: Rodent and Pest Control of your SE prevention plan, which calls for weekly monitoring of the rodent traps.
The above violations are not meant to be an all-inclusive list of deficiencies 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 FD&C Act, the PHS Act, and the shell egg regulation. You also have the responsibility to use procedures to prevent future violations of these statutes and regulations.
Additionally, FDA suggests that you review and enhance your procedures for limiting access to your farm to ensure that you are complying with the requirement to limit visitors on the farm and in the poultry houses (21 CFR 118.4(b)(1)). Investigators observed that you have a visitor sign in log as part of your procedures to limit visitors on your farm. However, during the inspection our investigators noted that there is unobstructed access to your poultry house. In order to limit unauthorized access, you may want to consider fencing around the perimeter of your farm, the inclusion of signage stating that unauthorized visitors are prohibited, or something as simple as adding locks to your poultry house entryways.
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. Your response should include any documentation necessary to show that corrective action has been achieved, such as an SE Prevention Plan. If you cannot complete all corrections within fifteen (15) working days, you should explain the reason for your delay and the time within which the remaining corrections will be completed.
Please send your reply to the attention:
Director, Compliance Branch
U.S. Food and Drug Administration
Division of Human and Animal Foods – West II 8050
Marshall Drive - Suite 205
Lenexa, Kansas 66214
If you have any questions regarding any issue in this letter, please contact Monica M. McClure, Compliance Officer at 316-315-0017 ext. 1004.
Cheryl A. Bigham Director
Kansas City District Office
Division of Human and Animal Foods West II