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  5. Christopher Dale Butler - 720334 - 01/09/2026
  1. Warning Letters

WARNING LETTER

Christopher Dale Butler MARCS-CMS 720334 —

Delivery Method:
VIA ELECTRONIC DELIVERY
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Christopher D. Butler
Recipient Title
Owner
Christopher Dale Butler

151 Southfield Cutoff
El Dorado, AR 71730-2227
United States

butlerquailfarm@yahoo.com
Issuing Office:
Human Foods Program

United States

January 9, 2026

WARNING LETTER

Re: CMS # 720334

Dear Mr. Butler,

The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) foods facility, located at 151 Southfield Cutoff, El Dorado, Arkansas from September 10 through 23, 2025. During our inspection, the FDA investigator found serious violations of the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108)) and Acidified Foods regulation (21 CFR Part 114).

As an acidified food processor, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the federal regulations related to the processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR Part 108, Emergency Permit Control and in 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulation was issued, in part, pursuant to section 404 of the Act [21 U.S.C. § 344]. A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114.

Based on FDA’s inspectional findings, we have determined your pickled quail egg products are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health. You can find the Act and FDA’s regulations through links in FDA’s homepage at www.fda.gov.

At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. To date, FDA has not received a response from you regarding the inspectional observations documented during the inspection of your facility. We are issuing this letter to advise you of FDA’s concerns.

Acidified Food Violations (21 CFR Part 108 and 114)

Your significant violations are as follows:

A scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and expertise in acidification and processing of acidified foods, as required by 21 CFR 114.83. Specifically, you manufacture RTE products including, but not limited to, your Convenient Gourmet brand of Jalapeno Pickled Quail Eggs and Cajun Pickled Quail Eggs. FDA has determined that your pickled quail egg products appear to meet the definition of acidified foods under 21 CFR 114.3(b). Therefore, a scheduled process must be established in compliance with 21 CFR 114.83.

This is a repeat observation from the FDA-483 issued to you on September 29, 2022.

In addition, as a commercial processor engaged in the (b)(4) processing of acidified foods, you must provide the FDA information as to the scheduled process including, as necessary, conditions for (b)(4) processing and control of pH, salt, sugar and preservative level, and source and date of the establishment of the process for each acidified food in each container size that you manufacture, as required by 21 CFR 108.25(c)(2). Although you have registered your facility as a Food Canning Establishment (FCE) with the FDA, this does not meet the requirement for submitting process filings, and you do not have an established scheduled process on file for your acidified food products, including but not limited to, Jalapeno Quail Eggs and Cajun Quail Eggs, as individually packaged into 16 oz. glass jars.

Scheduled process information for acidified foods must be submitted on Form FDA 2541e (Food Process Filing for Acidified Method). As stated above, your manufactured processes (scheduled processes) must be established by a qualified person who has expert knowledge acquired through appropriate training and expertise in acidification and processing of acidified foods, and provide that information to the FDA, for each product you manufacture, and for each container size. Once established, you are also required to follow Emergency Permit Control and Acidified Foods regulations, as identified in 21 CFR 108 and 114, including, but not limited to, the monitoring and documentation of process controls, as well as record and reporting requirements, as identified in 21 CFR 114.800 and 21 CFR 114.100.

More information regarding registration and filing can be found in the publication: Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541D, FDA 2541e, FDA 2541fF, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format, as available at: Guidance for Industry: Submitting Forms for Food Canning Establishment Registration and Food Process Filing to FDA in Electronic or Paper Format | FDA.

The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist at your facility, or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your facility complies with all requirements of federal law, including applicable FDA regulations.

Additionally, we offer the following comments:

  • We have determined that your facility has failed to renew your registration for the 2024 bi-annual renewal year. Your facility is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d], and FDA's implementing regulation at 21 CFR Part 1, Subpart H [21 CFR 1.225 - 1.243]. The failure to register a facility, as required, is a prohibited act under section 301(dd) of the Act [21 U.S.C. § 331(dd)]. Our records indicate that, to date, your facility is not a registered with FDA. As the owner, operator, or agent in charge of your facility, you, or an individual authorized by you, must register your facility with FDA immediately.

Registration may be accomplished on-line at: http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number. A step-by-step guide on registration renewal can also be found at Food Facility Registration User Guide: Biennial Registration Renewal | FDA. If you need assistance with logging into the registration portal, PIN, or renewing your registration, you may contact the FDA at the Food Facility Registration Data Management Support Services (FFRDMSS): by phone 1-800-216-7331 or 240-247-8804; or by email at FURLS@fda.gov. A reference sheet concerning your DUNS number is also available, as applicable.

  • You did not prepare and maintain files on current procedures for recalling products that may be injurious to health, identifying, collecting, warehousing, and controlling products, determining the effectiveness of recalls, notifying FDA of recalls and implementing recall programs. For guidance on recall plan development, we recommend you review FDA’s Hazard Analysis and Risk Based Preventive Controls, Draft Guidance for Industry, Chapter 14. This guidance provides background on recall plan development and the necessary requirements of a recall plan.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

Please notify FDA in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing copies of related documents. If you cannot complete all corrections within fifteen (15) days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: Amy Glynn, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Amy Glynn via email at: amy.glynn@fda.hhs.gov. Please include reference #720334 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, JD, MBA
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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