FDA Warns Iowa Egg Company, A Houston-Based Firm

The U.S. Food and Drug Administration (FDA) issued a warning letter to Iowa Egg Company. The letter was addressed to the Houston office for the Osage, Iowa-based egg manufacturing facility due to ongoing violations. In an official letter, the FDA warns Iowa Egg Company, Inc. to comply with appropriate egg facility requirements and bring the facility up to code.

What is an FDA Warning Letter?

The FDA issues warning letters, like this one where the FDA warns Iowa Egg Company, to serve as an official notification. According to the agency, a warning letter is issued “when the FDA finds that a manufacturer has significantly violated FDA regulations.”

Common reasons for a warning letter include:

• Poor manufacturing practices
• Problems with claims for what a product can do
• Incorrect directions for use
• Violation of FDA requirements

These warning letters are not the first form of communication, and often result from repeated violations or failure to correct FDA complaints.

Once a warning letter is issued, the firm has 15 days to satisfactorily respond. If that compliance is not met, additional FDA actions may occur that include, but are not limited to requiring the facility to close.

Contents of Iowa Egg Company Warning Letter

The letter, addressed to Mr. Danny Dang, was submitted on December 15, 2023 in reference to the case #663904.

The letter discusses the inspection performed over the Summer at the farm and facility that is located in Osage, Iowa by the Iowa Department of Agriculture. Serious violations of the federal shell egg regulations (Title 21, Code of Federal Regulations, Part 118) were observed.

As a result, eggs originating from the facility are considered “adulterated” 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.”

The facility, located at 3407 Kirkwood Ave., in Osage, Iowa houses the egg farm and processing facility where the eggs are washed, graded, and packed. Since the inspection in June, the department has not received a response indicating corrective actions to bring the facility back up to code.

FDA Warns Iowa Egg Company of Violations

Several violations, ranging from written plans to facility conditions were noted.

Some of the violations included:

Written Salmonella Enteritidis (SE) Prevention Plan Missing Key Components

FDA Warns Iowa Egg Company that they do not have a written SE plan. This is a written document that describes measures taken by the firm to prevent the spread of Salmonella Enteritidis. This is a required document for shell egg farms and facilities.

This type of document has minimum requirements that must be addressed. Things like conditions and testing requirements for raised and procured pullets (female chickens) to help prevent the spread of Salmonella. Biosecurity measures such as visitor contact with the birds, ways cross-contamination can be prevented, and how to keep stray or wild animals out of poultry houses, among other conditions.

Ineffective Pest Control and Pest Control Requirements

In the letter, the FDA warns Iowa Egg Company about written pest control requirements and monitoring activities, as well as citing violations observed during the inspection. Rodent activity, excess flies, as well as poor lawn maintenance and debris were cited around the poultry house.

Egg Handling Temperatures Outside of Limits

The minimum temperature and time requirements stated in the facilities SE Prevention Plan were not met. This information was found on documentation on-site for egg holding coolers.

Environmental Testing Requirements Were Not Met

While environmental testing was performed as required for SE, the testing was not performed at the appropriate ages noted in the Shell Egg Regulations registry. Additional inconsistencies were observed when it came to samples sent to the laboratory for testing.

Other Observations

In addition to the violations to Shell Egg Regulations, additional observations were noted in the FDA warning letter.

Uncaged Birds Found Running Around

Inspectors observed uncaged birds running around the floor of the “belted house.” These birds were not returned immediately to their designated areas. This poses a cross-contamination problem and violates established SE Prevention Plan guidelines. While the matter may seem minor, birds out of their designated areas can spread Salmonella. If the birds aren’t properly placed back, a single bird can infect a large number of the flock.

Farm is Unregistered

The farm is also not registered with the FDA as an egg farm. When an egg farm reaches a certain number of laying hens and/or the farm does not sell all of their eggs directly to the consumer, it must be registered with the FDA.

At the time of the letter, the farm’s registration was not accurate. The current owner of the farm must be indicated on the FDA registration.

What Happens if a Company Does Not Respond to a Warning Letter?

Most warning letters come with a statement indicating that “within fifteen working days of receipt of this letter, please notify this office in writing of specific steps you have taken to correct violations.”

This response usually requires specific answers to all of the statements included in the warning letter. It should also include the corrective actions taken, and what actions are being performed to prevent the violation from happening again.

But what happens if a company does not respond?

It is a fair question, as a warning letter is generally issued only after subsequent violations and/or no response to the noted violations.

In some cases, it means legal action such as seizure or mandated closure of the facility. Other administrative enforcement procedures, such as onsite FDA inspectors could be required. This activity is likely not optional or free.

It is in the best interest of all involved to respond appropriately to the warning letter.

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By: Heather Van Tassell (Contributing Writer, non-lawyer)