WARNING LETTER
Ogle Cattle Company, Inc.
MARCS-CMS 713311 —
September 05, 2025
Delivery Method:
VIA EMAIL WITH READ RECEIPT: NO HARD COPY TO FOLLOW
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
James C. Ogle, Co-owner
Recipient Title
Julie D. Cook, Co-owner
Ogle Cattle Company, Inc.
312 Cattle Pen Road
Bowie
,
TX
76230-1166
United States
(b)(6)
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
CMS # 713311
September 05, 2025
Dear Mr. James Ogle and Mrs. Julie Cook,
An inspection of your cattle feedlot operation, Ogle Cattle Company, Inc. located at 312 Cattle Pen Road, Bowie, Texas 76230-1166, was conducted by a representative of the U.S. Food and Drug Administration (FDA) on April 17, April 18, May 6, and June 10, 2025. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that we found during our inspection of your operation. You can find the FD&C Act and its associated regulations on the internet through links on FDA’s web page at www.fda.gov.
At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). We have not received a response to the FDA 483 as of the date of this letter.
Adulteration of Animals Offered for Human Consumption
Our inspection found you offered for sale animals for slaughter as food that were adulterated. Specifically, you sold the following animals at auction for slaughter as food:
You sold a steer identified with backtag
(b)(4)
at auction on or about
(b)(4)
. The animal was slaughtered on or about
(b)(4)
, at
(b)(4)
. The United States Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the animal identified the presence of desfuroylceftiofur at 9.44 parts per million (ppm) in kidney tissue.
You sold a heifer identified with backtag
(b)(4)
at auction on or about
(b)(4)
. The animal was slaughtered on or about
(b)(4)
, at
(b)(4)
. USDA/FSIS analysis of tissue samples collected from the animal identified the presence of desfuroylceftiofur at 0.846 ppm in kidney tissue.
You sold a heifer identified with backtag
(b)(4)
at auction on or about
(b)(4)
. The animal was slaughtered on or about
(b)(4)
, at
(b)(4)
. USDA/FSIS analysis of tissue samples collected from the animal identified the presence of desfuroylceftiofur at 2.04 ppm in kidney tissue.
You sold a steer identified with backtag
(b)(4)
at auction on or about
(b)(4)
. The animal was slaughtered on or about
(b)(4)
, at
(b)(4)
. USDA/FSIS analysis of tissue samples collected from the animal identified the presence of desfuroylceftiofur at 0.520 ppm in kidney tissue.
FDA has established a tolerance of 0.4 ppm of desfuroylceftiofur, a marker residue of ceftiofur drugs, in the kidney tissue of cattle.
1
The presence of this drug in the edible tissues of these animals at these levels cause the food to be adulterated. A food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe.
2
A drug is unsafe if it results in any residues that exceed any established safe levels.
3
The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.
4
Additionally, our inspection found that you hold animals under conditions that are inadequate such that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Specifically, you failed to keep identity records or record existing identification of animals you purchased and/or delivered for sale, you did not maintain treatment records for drugs administered to cattle on your farm, nor did you identify or segregate animals you treated with drugs. Food held under conditions whereby it may have been rendered injurious to health is adulterated.
5
Adulteration of a New Animal Drug
Our inspection found you did not use
(b)(4)
as directed by its approved labeling. Use of a drug in a manner that is not consistent with its labeling is extralabel use.
6
Our inspection found that you administered
(b)(4)
to cattle without following the approved route of administration. During the inspection, you stated that you administer all medications as a subcutaneous injection in the neck area or over the ribs of animals receiving medical treatment. This drug is labeled for administering to cattle as
(b)(4)
.
(b)(4)
, a ceftiofur class drug, is prohibited from extralabel use at unapproved routes of administration in food-producing animals.
7
The extralabel use of this drug is only allowed if it complies with the FD&C Act and 21 CFR Part 530 including that such use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship.
8, 9
Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused the drug to be unsafe and adulterated.
10
The introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act.
11
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility. 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.
We would like to note that your use of
(b)(4)
(enrofloxacin), without maintaining treatment records and/or segregating or identifying medicated animals, resulted in the detection of ciprofloxacin, a marker residue of enrofloxacin, in the cattle listed above by USDA/FSIS. Ciprofloxacin has a tolerance of 0.1 ppm in the liver of cattle.
12
Care should be taken to ensure
(b)(4)
is administered according to its label and that the appropriate withdrawal time is followed. Use of
(b)(4)
, a fluoroquinolone drug, is prohibited from extralabel use.
13
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 you have complied with the FD&C 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.
Please direct your electronic correspondence to Compliance Officer Dylan C. Grippi at dylan.grippi@fda.hhs.gov. If you are unable to submit your correspondence electronically, please direct it to the attention of Dylan C. Grippi, Compliance Officer, at the following address:
U.S. Food and Drug Administration
Center for Veterinary Medicine
CPK1, 5001 Campus Drive
College Park, MD 20740-3835
If you have questions regarding this letter, please contact Compliance Officer Dylan C. Grippi by telephone at (301) 452-1608, or by email at dylan.grippi@fda.hhs.gov.
Sincerely,
/S/
Isaac K. Carney
Director of Food Compliance, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
CC:
(b)(4)
(b)(6)
________________________
1
See 21 CFR 556.113(b)(1)(i).
2
See section 402(a)(2)(C)(ii) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(ii)].
3
See section 512(a)(4)(B) of the FD&C Act [21 U.S.C. § 360b(a)(4)(B)].
4
See section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
5
See section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)].
6
See 21 CFR 530.3(a).
7
See 21 CFR 530.41(a)(13)(ii).
8
See section 512(a)(4) and (5) of the FD&C Act [21 U.S.C. § 360b(a)(4) and (5)].
9
See 21 CFR 530.3(i)(1).
10
Under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)], a new animal drug is deemed adulterated if it is unsafe within the meaning of section 512 of the FD&C Act [21 U.S.C. § 360b].
11
See section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
12
See 21 CFR 556.226(b)(1).
13
See 21 CFR 530.41(a)(10).
Content current as of:
09/30/2025
Regulated Product(s)
Animal & Veterinary
Drugs