WARNING LETTER
King Farm
MARCS-CMS 713276 —
December 04, 2025
Delivery Method:
VIA UPS
Product:
Animal & Veterinary
Recipient:
Recipient Name
Henry B. King
Recipient Title
Owner
King Farm
1259 Sharon Hill Rd
Dover
,
DE
19904-4660
United States
(b)(6)
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
CMS # 713276
December 4, 2025
Dear Mr. King,
The United States Food and Drug Administration (FDA) conducted an inspection of your non-FDA licensed feed mill that manufactures non-medicated animal food, located at 1259 Sharon Hill Road, Dover, Delaware, from June 16 through June 19, 2025. This inspection was initiated after FDA became aware of at least 30 horse deaths and potentially one goat death after consuming your animal food products that were contaminated with the mycotoxin fumonisin. You stated to have recalled all potentially contaminated horse food products on approximately May 1, 2025. During the inspection, FDA collected samples of your recalled King’s All Stock Feed, King’s Horse Feed 12-6 Blend, Byler Mix, and an unlabeled customer-formula all stock feed. Analysis performed by FDA found your products contained excessive levels of fumonisin, with total fumonisin levels ranging from 18 parts per million (ppm) to 36.1 ppm. These fumonisin levels are above FDA’s recommended limit for equids, which is 5 ppm for corn products not to be included at more than 20% of the diet (i.e., 1 ppm in complete animal food for equids).
1
FDA analytical results for fumonisin levels in your finished animal food are as follows:
1. Sample 1262823, King’s All Stock Feed, unspecified lot number, contained 32.5 ppm in original and 29.3 ppm in check composite analysis.
2. Sample 1262824, King’s Horse Feed 12-6 Blend, unspecified lot number, contained 18.0 ppm in original and 19.1 ppm in check composite analysis.
3. Sample 1262825, Byler Mix, unspecified lot number, contained 36.1 ppm in original and 32.3 ppm in check composite analysis.
4. Sample 1302946, unlabeled customer-formula all stock feed collected at hauler, unspecified lot number, contained 28.9 ppm in original and 30.8 ppm in check composite analysis.
FDA considers the products sampled to be adulterated in that they bear or contain a poisonous or deleterious substance which may render them injurious to health.
2
During the inspection, FDA also documented evidence of violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements located in Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507), which cause your products to be adulterated in that they were 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.
3
The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.
4
(b)(3)(A)
5, 6, 7
, you failed to report a reportable food to the Reportable Food Registry (RFR) within twenty-four hours of determining that it is a reportable food (i.e., an animal food for which there is a reasonable probability that the use of, or exposure to, such animal food will cause serious adverse health consequences or death to animals).
8
Failure to submit a required reportable food report is a prohibited act.
9
This letter notifies you of the violations of the FD&C Act that we found during our inspection of your operation. You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). As of the date of this letter we have not received a written response. We address below the operational changes we observed during the inspection.
Current Good Manufacturing Practices (CGMP) Requirements for Animal Food
Your animal food facility is subject to the CGMP requirements found in 21 CFR Part 507, subparts A, B, and F. During the inspection of your facility, the FDA investigators observed the following violation of these requirements:
You failed to evaluate and use raw materials and other ingredients susceptible to contamination with mycotoxins or other natural toxins in a manner that does not result in animal food that can cause injury or illness to animals or humans, as required by 21 CFR 507.25(b)(2).
Your firm manufactures animal food using grain and grain by-products such as corn and wheat which are known to be susceptible to mycotoxin contamination. However, you did not have procedures in place, conduct routine testing, or have any processes in place to determine whether mycotoxins such as fumonisin, aflatoxin, or deoxynivalenol (DON/vomitoxin) are present at levels that can cause injury or illness to animals or humans in these grain and grain co-products you receive, store, and use in your animal food products.
On March 24, 2025, you received
(b)(4)
of corn from
(b)(4)
. You did not evaluate this corn for mycotoxins and later used the corn to manufacture finished animal food products including King’s All Stock Feed, King’s Horse Feed 12-6 Blend, King’s Horse Feed 10-5 Blend, King’s 10% Horse Feed,
(b)(4)
, Byler Mix, and Miller Mix. Your King’s All Stock is labeled for all animals which you stated includes horses, goats, sheep, and other ruminants. You were notified the goat that died had been fed the same King’s All Stock Feed animal food as a horse that also died after consuming the feed on the farm. You were initially notified of illnesses and deaths to horses by customers and third-party veterinarians on or around April 9, 2025. You discovered the horse foods were contaminated with elevated levels of fumonisin while working with third-party veterinarians and state regulatory agencies on or about May 1, 2025, at which point you recalled your animal food products made with suspected fumonisin-contaminated corn.
Furthermore, you had a third-party laboratory conduct mycotoxin analysis of your recalled products and corn ingredients which support that your lack of raw material evaluation led to products becoming adulterated. The results also document contamination with fumonisin and include the following:
1. Sample No.
(b)(4)
, King’s All Stock Feed product, reports total fumonisin at 43.44 ppm.
2. Sample No.
(b)(4)
, King’s Horse Feed 10-5 Blend product, reports total fumonisin at 28.13 ppm.
3. Sample No.
(b)(4)
, corn ingredient, reports total fumonisin at 9.18 ppm.
4. Sample No.
(b)(4)
, corn ingredient, reports total fumonisin at
(b)(4)
ppm.
During the inspection we noted that you made changes to your operations after receiving notification of animal deaths. These changes included sampling your raw materials for mycotoxins and working to build a mycotoxin evaluation program. However, by the close of the inspection you did not establish a procedure to evaluate mycotoxins in incoming raw materials based upon the intended species of your animal food. You also did not respond to the FDA 483 to demonstrate your operational changes were adequate and sustainable. We encourage you to provide us with documentation of implementation of your corrections in follow-up correspondence.
(b)(3)(A)
Reportable Food Registry (RFR)
You failed to report a reportable food to the RFR within 24 hours of determining that it is reportable food (an article of food for which there is reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals), as required by section 417(d)(1) of the FD&C Act [21 U.S.C. § 350f(d)(1)].
Specifically, on or about April 9, 2025, you became aware of horse illnesses and deaths from consuming your animal food products, and on or about May 1, 2025, you became aware that the animal food you manufactured was likely contaminated with fumonisin. You received third-party analysis results, dated May 28, 2025, documenting excessive fumonisin levels for your King’s All Stock Feed and King’s Horse Feed 10-5 Blend feeds. You have not filed a RFR report as of the date of this letter.
The RFR was established to provide a reliable mechanism to track patterns of adulteration in food (including animal food) to support efforts by FDA to target limited inspection resources to protect public health. It requires a “responsible party” to file reportable food reports. The responsible party is the person who submits the registration under section 415 of the FD&C Act required for a food facility that is required to register, at which the reportable food was manufactured, processed, packed, or held.
10
The responsible party is required to file a notification within 24 hours of determining that an article of food is a reportable food. Failure to submit a required reportable food report is a prohibited act under the FD&C Act.
11
Conclusion
This letter is not intended to be an all-inclusive statement 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 you comply with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to legal action, including without limitation, seizure, and injunction.
For more information about FDA’s current thinking on the requirements of 21 CFR Part 507, mycotoxins, and registration, see the below links and attachments to this letter:
Guidance for Industry #235, Current Good Manufacturing Practice Requirements for Food for Animals
https://www.fda.gov/media/97464/download
Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-fumonisin-levels-human-foods-and-animal-feeds
Guidance for Industry and FDA: Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products and Grains and Grain By-Products used for Animal Feed
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-and-fda-advisory-levels-deoxynivalenol-don-finished-wheat-products-human
Compliance Policy Guide, Sec. 683.100, Action Levels for Aflatoxins in Animal Food
https://www.fda.gov/media/121202/download
Animal Food Facility Registration and Qualified Facility Attestation: Frequently Asked Questions
https://www.fda.gov/animal-veterinary/animal-foods-feeds/animal-food-facility-registration-and-qualified-facility-attestation-frequently-asked-questions
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe your products are not in violation of the Act and FDA regulations, include your reasoning and any supporting information for our consideration.
The Food & Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance is encouraging electronic submission of any response you choose to submit to this letter. We encourage you to submit files up to 100 megabytes in a single email, and to divide files greater than 100 megabytes so they may be submitted as smaller files in separate emails. If you submit electronic correspondence, please ensure that your facility’s name, the CMS number at the top of this letter, and the inspection location are included in your correspondence. We intend to issue an electronic acknowledgement upon receipt of your email. If you are unable to submit your correspondence electronically, please direct it to the attention of Andrew Howard, Compliance Officer, at the following address:
United States Food & Drug Administration
Center for Veterinary Medicine
Office of Surveillance and Compliance
Division of Food Compliance
CPK1, 5001 Campus Drive
College Park, Maryland 20740-3835
If you have questions regarding this letter, please contact Compliance Officer Andrew Howard by telephone at (410) 779-5125, or by email at Andrew.Howard@fda.hhs.gov.
/S/
Isaac K. Carney
Director of Food Compliance, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
Attachments:
1. Guidance for Industry #235, Current Good Manufacturing Practice Requirements for Food for Animals
2. Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds
3. Guidance for Industry and FDA: Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products and Grains and Grain By-Products used for Animal Feed
4. Compliance Policy Guide, Sec. 683.100, Action Levels for Aflatoxins in Animal Food
5.
(b)(3)(A)
6.
(b)(3)(A)
cc:
(b)(6), (b)(7)(C)
______________________
1
See “Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds,” below. Fumonisin levels above 1.0 ppm are known to cause liver disease and fatal nervous system damage in horses.
2
See Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(1)].
3
See Section 402(a)(4) of the FD&C Act [21 U.S.C. 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).
4
See Section 301(a) of the FD&C Act [21 U.S.C. 331(a)].
5
See section 415 of the FD&C Act [21 U.S.C. § 350d].
6
See 21 CFR Part 1, Subpart H.
7
See Section 301(dd) of the FD&C Act [21 U.S.C. § 331(dd)].
8
See Section 417(d) of the FD&C Act [21 U.S.C. § 350f(d)].
9
See Section 301(mm) of the FD&C Act [21 U.S.C. § 331(mm)].
10
See Sections 415 and 417(a)(1) of the FD&C Act [21 U.S.C. §§ 350d and 350f(a)(1)].
11
See Section 301(mm) of the FD&C Act [21 U.S.C. § 331(mm)].
Content current as of:
12/23/2025
Regulated Product(s)
Animal & Veterinary