WARNING LETTER
Circle G Farm & Feed Lots Inc
MARCS-CMS 564195 —
October 16, 2018
Product:
Animal & Veterinary
Food & Beverages
Animal Drugs
Unapproved Animal Drugs
Recipient:
Recipient Name
Robert E. Groenhagen
Recipient Title
President
Circle G Farm & Feed Lots Inc
Circle G Farm & Feed Lots Inc
3720 East Limerick Road
Oregon
,
IL
61061
United States
Issuing Office:
Chicago District Office
United States
WARNING LETTER
FY2019-HAFE6-01
October 16, 2018
VIA UPS
Robert E. Groenhagen, President
Gary R. Groenhagen, Vice President
Circle G Farms & Feed Lots Inc.
3720 East Limerick Road
Oregon, Illinois 61061
Dear Messrs. Groenhagen,
On July 11, 2018 and July 19, 2018, the United States Food and Drug Administration (FDA) conducted an inspection of your feeder cattle operation located at 3720 East Limerick Road, Oregon, Illinois.  This letter notifies you of the violations of the Federal, Food, Drug and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation.  You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page
www.fda.gov
.
We found that you offered for sale an animal for slaughter as food that was adulterated.  Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b.  Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about December 20, 2017, you sold a culled steer, identified with ear tag #
(b)(4)
and back tag #
(b)(4)
, for slaughter as food.  On or about December 20, 2017,
(b)(4)
, slaughtered this animal.  The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 4.785 parts per million (ppm) of sulfamethazine in the liver tissue.  FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in uncooked edible tissues of cattle, as codified in Title 21,
Code of Federal Regulations
(CFR), 556.670 (21 CFR § 556.670).  The presence of sulfamethazine in edible tissue from this animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.   You failed to maintain any treatment records.  You also failed to adequately identify treated animals.  Specifically, you stated that you typically
(b)(4)
of treated animals; however, you failed to
(b)(4)
of steer with ear tag #
(b)(4)
.  Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
We also found that you adulterated the new animal drug
(b)(4)
.  Specifically, our investigation revealed that you did not use
(b)(4)
as directed by its approved labeling.  Use of this drug in this manner is an extralabel use, as defined by 21 CFR § 530.3(a).
Our investigation found that you administered
(b)(4)
orally for gut issues to a steer without following the route of administration and approved conditions as stated in the approved labeling.  According to its labeling,
(b)(4)
is only to be given to treat
(b)(4)
and to be given by subcutaneous injection.  Your use of
(b)(4)
to treat gut issues and administration to the steer orally was therefore extralabel use.  Under 21 CFR § 530.41(a) (10), fluoroquinolones, including
(b)(4)
, are prohibited from extralabel use.  Because your use of this drug was not in conformance with the approved labeling, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360(b)(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
The above is not intended to be an all-inclusive list of violations.  As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur.  Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.
We would like to note that your extralabel use of
(b)(4)
resulted in the detection of
(b)(4)
(marker residue
(b)(4)
) in the liver of steer with ear tag #
(b)(4)
.
(b)(4)
(marker residue for
(b)(4)
) has a tolerance of 0.1 ppm in the liver of cattle, 21 CFR § 556.226.  Care should be taken to ensure
(b)(4)
is administered according to its label and that the appropriate withdrawal time is followed.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter.  Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence.  If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed.  Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Dr. Byron Ho, DVM, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207.  If you have any questions about this letter, please contact Dr. Ho at (313) 393-8262 or email at
byron.ho@fda.hhs.gov
.
Sincerely,
/S/
William R. Weissinger, MS
Chicago District Director
Office of Human and Animal Food Operations
Division East 6
CC:
(b)(4)
Mark Ernst, Bureau Chief/State Veterinarian
Illinois Department of Agriculture – Bureau of Animal Health and Welfare
801 E. Sangamon Ave.
PO Box 19281
Springfield, IL 62794
Paul Wolseley, District Manager
United States Department of Agriculture
Food Safety and Inspection Service
1919 South Highland Ave.
Suite 115C
Lombard, IL 60148
Content current as of:
10/30/2018
Regulated Product(s)
Animal & Veterinary
Food & Beverages
Animal Drugs
Topic(s)
Unapproved Animal Drugs