As part of its enforcement activities, the Food and Drug Administration sends out alerting letters to entities under its jurisdiction. Some letters are not published for public view till weeks or months after they are sent out. Entrepreneur have 15 days to react to FDA cautioning letters. Caution letters typically are not provided up until a business has actually been provided months to years to fix issues.
Iowa Egg Company Inc.
Houston, TX
In a Dec. 15, 2023, cautioning letter, the Food and Drug Administration alerted the owner of an egg business about Salmonella issues in his center.
On June 28-29, 2023, the Iowa Department of Agriculture, under agreement with the Food and Drug Administration (FDA), examined the shell egg farm and egg processing center, where eggs are cleaned, graded, and loaded. The assessment exposed major infractions of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation guideline (the Shell Egg guideline), Title 21, Code of Federal Regulations, Part 118 (21 CFR Part 118).
Failure to abide by the arrangements of 21 CFR 118 triggers your shell eggs to be in infraction of area 361(a) of the general public Health Service Act (the PHS Act), 42 U.S.C. § 264(a). In addition, these offenses render your shell eggs adulterated within the significance of area 402(a)( 4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)( 4 ), because they have actually been prepared, loaded, or held under insanitary conditions whereby they might have ended up being infected with dirt, or whereby they might have been rendered damaging to health. You might discover the Act, the PHS Act and Shell Egg policy through links on FDA's web page at www.fda.gov.
At the conclusion of the evaluation, Iowa Department of Agriculture State inspectors provided an FDA Form 483 Inspectional Observations. To date, FDA has actually not gotten a reaction explaining restorative actions. Based upon our evaluation of the inspectional findings, we are releasing this letter to encourage you of our issues and to supply comprehensive info explaining the findings at your farm. Your substantial offenses are as follows:
You did not have and carry out a composed Salmonella Enteritidis (SE) Prevention Plan that consists of, at minimum, the SE avoidance procedures needed by 21 CFR118.4. You have actually a file entitled “SE Prevention Plan”; nevertheless, as explained listed below, this strategy is insufficient because it does not deal with all needed SE avoidance steps.
You did not have actually composed procedures to guarantee that there is no intro or transfer of SE into or amongst poultry homes, as needed by 21 CFR 118.4(b). At a minimum, you need to:
- Limitation visitors on the farm and within the poultry homes;
- Preserve workers and devices practices that will safeguard versus cross-contamination when individuals or devices relocation in between homes;
- Avoid roaming poultry, wild birds, felines, and other animals from going into poultry homes;
- Not enable staff members to keep birds in the house.
