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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Cheyenne Dairy No. 2 29-May-08

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Klpling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100


 

May 29, 2008

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. DavidA. Hoekstra
Owner
Cheyenne Dairy No. 2
185 East Calusa Road
Dexter, NM 88230

Ref. #: DEN-08-14

Dear Mr. Hoekstra:

An inspection of your dairy operation located at 207 East Calusa Road,Dexter, New Mexico conducted by a representative of the U.S. Food and Drug Administration (FDA) on January 9 -14, 2008, confirmed that you offered animals for sale for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. §342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342 (a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drug Penicillin G Procaine Injectable Suspension U.S.P. to become unsafe under section 512(a) of the Act [21 U.S.C § 360b(a)] and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. §351(a)(5)]. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

On October 22, 2007, you sold a dairy cow, with identifying ear tag [redacted] for slaughter as food to [redacted]. On October 22, 2007, the animal was slaughtered and United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.61 ppm Penicillin in the kidney tissue. A tolerance of 0.05 ppm has been established for residues of Penicillin in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.510 (21 C.F.R. § 556.5 10). The presence of this drug in the edible tissues of this animal in amounts exceeding the tolerance set out in 21 CFR§ 556.510 causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act [21 U.S.C. § 342(a)(2)(C)(ii)].

On September 28, 2007, you sold a dairy cow, with identifying ear tag [redacted] for slaughter as food to [redacted]. On September 28, 2007, the animal was slaughtered and USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 0.611 ppm Flunixin in the liver tissue and 0.038 ppm Flunixin in the muscle tissue. A tolerance of 0.125 ppm has been established for residues of Flunixin in liver tissue and a tolerance of 0.025 ppm has been established for residues of Flunixin in muscle tissue of cattle, as codified in 21 C.F.R. § 556.286. The presence of this drug in the edible tissues of this animal in amounts exceeding the tolerance set out in 21 § 556.286 cause the food to be adulterated within the meaning of the section 402(a)(2)(C)(ii) of the 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 lack an adequate system to ensure that animal medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain complete treatment records prior to selling animals.for slaughter. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4)of the Act[21 U.S.C. §342(a)(4)].

In addition, you adulterated Penicillin G Procaine Injectable Suspension U.S.P. within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] when you failed to use the drug in conformance with its approved labeling. "Extralabel. use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. §§ 360b(a)(4) and 360b(a)(5)], and 21 C.F.R. Part 530. Our investigation found that your extralabel use of Penicillin G Procaine Injectable Suspension U.S.P. failed to comply with these requirements.
 

For example, you administered the Penicillin G Procaine Injectable Suspension U.S.P. without following the dosage level set forth in the approved labeling. You administered three times the recommended dose and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d). Because your extralabel use of this drug was not in compliance with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and your use caused it to be adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)].

The above is not intended to be an all-inclusive list of violations. As a producers 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 above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

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, 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 William H. Sherer, Compliance Officer, U.S. Food and Drug Administration, P.O. Box2 5087, Denver, Colorado 80225-0087. If you have any questions about this letter please contact Compliance Officer Sherer at the above address, via telephone at (303) 236-3051, or by email at william.shera@fda.gov.
 

Sincerely,

/S/
 

H. Thomas Warwick
Denver District Director

cc:
Ronald C. Nelson, D.V.M.
Denver District Director
USDA/FSIS
PO Box 25387
DFC, Bldg 45
Denver, CO 80225

I. Miley Goinzalez, Ph.D.
Secretary
New Mexico Department of Agriculture
New Mexico State University
P.O. Box 300005, MSC 3189
Las Cruces, NM 88003-8005