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WARNING LETTER

Iowa Egg Company Inc. MARCS-CMS 663904 —


Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages

Recipient:
Recipient Name
Danny Dang
Recipient Title
Director/Owner
Iowa Egg Company Inc.

2010 Holmes Rd.
Houston, TX 77045
United States

Issuing Office:
Division of Human and Animal Food Operations West II

United States

Secondary Issuing Offices

United States


December 15, 2023

Reference Case #: 663904

WARNING LETTER

Dear Mr. Dang:

On June 28-29, 2023, the Iowa Department of Agriculture, under contract with the Food and Drug Administration (FDA), inspected your shell egg farm and egg processing facility, where your eggs are washed, graded, and packed, located at 3407 Kirkwood Ave., Osage, IA 50461. 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 Mr. Jose Hernandez, Site Manager, an FDA Form 483 (FDA-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:

1.  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 describedbelow, this plan is inadequate in that it does not address all required SE prevention measures.

Procurement of Pullets

Your SE Prevention Plan did not include requirements that procured pullets are SE-monitored or pullets are raised under SE-monitored conditions, as required by 21CFR 118.4(a)(1), and that the pullet environment will be tested for SE when pullets are 14-16 weeks of age, as required by 21 CFR 118.4(a)(2).

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 (b)(4) 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 (b)(4) 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 (b)(4) 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 (b)(4) 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°F ambient temperature beginning36 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 (b)(4)”; however, your cooler temperatures routinely exceeded 45°F. For example, from May 4, 2023, through June 4, 2023, the documented cooler temperatures ranged from 51°F to 68°Fconsecutively 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 (b)(4) house and the (b)(4) 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 (b)(4) house was sampled on February 27, 2023, with the date “on the bag” indicated as February25, 2023. Additionally, this laboratory record indicates that (b)(4) house was sampled on February 26, 2023, but indicates the date “on the bag” as February 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 violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your shell eggs. You are responsible for investigating and determining the cause of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that shell egg production practices are conducted in compliance with federal law and regulations including the Act, the PHS Act, and FDA’s egg safety rule.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).

In addition to the following violations, we also offer the following comments:

1)  Inspectors observed many uncaged birds running around the floor of the belted house. Farm management indicated that these birds would be caught and placed back in designated cages with no particular frequency. Not returning birds to cages with sufficient frequency creates the potential for further spread and cross-contamination of SE within a flock and farm if your poultry house were to be SE positive. You should manage loose birds on a daily basis, in addition to disposing of dead birds, spilled feed, manure, and refuse.

2)   Your farm is not currently registered as an egg farm with FDA under your current ownership. You must comply with the shell egg registration requirement since your farm has (b)(4) or more laying hens and at the time of the inspection was producing shell eggs for the table market and not selling all of the eggs directly to consumers. We encourage you to update your registration to accurately reflect your current operations.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If corrective actions cannot be completed within 15 working days of receipt of this letter, please state the reason for the delay and the timeframe within which the corrections will be completed. If you believe that you have complied with pertinent laws and regulations, include your reasoning and any supporting documentation for our consideration.

Your written response should be sent to the following address: U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214, to the attention of Kara L. Roden, Compliance Officer. If you need additional information or have questions, please contact CO Roden at 913-495-5121 or via email at: kara.roden@fda.hhs.gov.

Sincerely,
/S/

LaTonya M. Mitchell, Ph.D.
Program Division Director
Human and Animal Food Division -West II

CC:

Mr. Jose Hernandez, Site Manager
Iowa Egg Company Inc.
3407 Kirkwood Ave.,
Osage, IA 50461

 
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