As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Iowa Egg Company Inc.
Houston, TX
In a Dec. 15, 2023, warning letter, the Food and Drug Administration warned the owner of an egg company about Salmonella concerns in his facility.
On June 28-29, 2023, the Iowa Department of Agriculture, under contract with the Food and Drug Administration (FDA), inspected the shell egg farm and egg processing facility, where eggs are washed, graded, and packed. The inspection revealed 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 Part 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 Shell Egg regulation through links on FDA’s home page at www.fda.gov.
At the conclusion of the inspection, Iowa Department of Agriculture State inspectors issued an FDA Form 483 Inspectional Observations. To date, FDA has not received a response describing corrective actions. Based on our review of the inspectional findings, we are issuing this letter to advise you of our concerns and to provide detailed information describing the findings at your farm. Your significant violations are as follows:
You did not have and implement a written Salmonella Enteritidis (SE) Prevention Plan that includes, at minimum, the SE prevention measures required by 21 CFR118.4. You have a document titled “SE Prevention Plan”; however, as described below, this plan is inadequate in that it does not address all required SE prevention measures.
Biosecurity
You did not have written measures to ensure that there is no introduction or transfer of SE into or among poultry houses, as required by 21 CFR 118.4(b). At a minimum, you must:
- Limit visitors on the farm and within the poultry houses;
- Maintain personnel and equipment practices that will protect against cross-contamination when people or equipment move between houses;
- Prevent stray poultry, wild birds, cats, and other animals from entering poultry houses;
- Not allow employees to keep birds at home.
Further, inspectors observed gaps for potential entry of pests and other animals to the poultry houses (including large gaps in the (redacted) house), perimeter exhaust fans missing their protective cages, and other fans with protective cages that were not securely fastened.
Rodents, Flies and Other Pest Control
You did not monitor for the presence of rodents by appropriate methods, as required by 21 CFR 118.4(c)(1). Specifically, you did not identify a threshold for acceptable or unacceptable activity, nor did you identify corrective actions to take if unacceptable activity was observed. Farm management stated that a pest control company visits the farm (redacted) and places bait stations on the inside and outside of the poultry houses. However, the bait consumption was not routinely monitored. Inspectors observed evidence of rodent activity, including droppings and chewed insulation in the (redacted) house.
- You did not monitor for the presence of flies by appropriate methods, as required by 21 CFR 118.4(c)(2). Specifically, you did not routinely monitor fly activity, did not identify a threshold for acceptable and unacceptable fly activity, and did not identify corrective actions to take if unacceptable activity was observed. Further, flies were observed in the (redacted) house.
- You did not remove debris within a poultry house and vegetation and debris outside your poultry house that may provide harborage for pests, as required by 21 CFR 118.4(c)(3). Specifically, inspectors observed tall grass and weeds growing immediately around the poultry houses.
Cleaning and Disinfection
Your SE Prevention Plan did not include cleaning and disinfection procedures for poultry houses, in the event that you have an environment test or egg test that was positive for SE at any point during the life of a flock, as required by 21 CFR 118.4(d).
2. You did not hold or transport eggs at or below 45 degrees F ambient temperature beginning 36 hours after the time of lay, as required by 21 CFR 118.4(e). Your SE Prevention Plan stated “eggs should be stored in a cooler that is (redacted)”; however, your cooler temperatures routinely exceeded 45 degrees F. For example, from May 4, 2023, through June 4, 2023, the documented cooler temperatures ranged from 51 degrees F to 68 degrees F consecutively for 31 days.
3. You did not conduct environmental testing for SE in your poultry houses when laying hens were 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, the (redacted) house and the (redacted) house were tested when the flocks were approximately 48 weeks of age.
Further, we have concerns regarding your handling of environmental samples. For example, the laboratory record dated March 3, 2023, indicates the sample receipt date as March 1, 2023. However, this record also indicates that the (redacted) house was sampled on Feb. 27, 2023, with the date “on the bag” indicated as Feb. 25, 2023. Additionally, this laboratory record indicates that (redacted) house was sampled on Feb. 26, 2023, but indicates the date “on the bag” as Feb. 14,2023. No further explanation was provided to clarify the testing timeframes and date submitted to the laboratory for analysis.
4. You did not maintain records regarding your SE Prevention Plan in accordance with the requirements set forth by 21 CFR 118.10. Specifically:
a. You did not have documentation that the pullet environment for your current flocks were tested for SE at 14-16 weeks of age, as required by 21 CFR118.10(a)(2).
b. You did not have documentation that refrigeration requirements were met; specifically, you did not have cooler temperature logs for seven of the 12 months reviewed, as required by 21 CFR 118.10(a)(3)(iv).
c. Your SE Prevention Plan was not dated and did not include the signatures of the person(s) who administers the plan, as required by 21 CFR 118.10(b)(3).
d. You did not keep your SE Prevention Plan onsite at your farm location, as required by 21 CFR 118.10(d). Inspectors requested your SE Prevention Plan and received a copy via email from your corporate office.
The complete warning letter can be found here.
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