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U.S. Department of Health and Human Services

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Enforcement Actions

Rocky Top Dairy 13-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 & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100


May 13, 2008

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 

Mr. Buster Goff
Owner
Rocky Top Dairy
11015 North Goff Place
Hobbs, NM 88242
 

Ref. #:DEN-08-13

Dear Mr. Goff:

An inspection of your dairy operation located at 5702 West Stiles Road, Lovington, New Mexico conducted by a representative of the U.S. Food and Drug Administration (FDA) on January 9-17, 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 drugs [redacted] injectable Suspension U.S.P., Neomycin and Flunixin to become unsafe under section 512(a) [21 U.S.C § 360b(a)] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.

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 September 18, 2007, you sold a Holstein cow, with identifying [redacted] for slaughter as food to
[redacted]. On September 18, 2007, [redacted]. The animal was slaughtered at [redacted] on or about September 20, 2007. USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 1.19 parts per million (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. § 556.510). The presence of this drug in this amount in edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [(21 U.S.C. §342(a)(2)(C)(ii)] of the Act.

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 animals 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. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Act.

In addition, you adulterated [redacted] Injectable Suspension U.S.P. within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act 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) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and 21 C.F.R. Part 530.

Our investigation found that your extralabel use of [redacted] injectable Suspension U.S.P. failed to comply with these requirements. For example, you administered the Injectable Suspension U.S.P. without following the dosage level set forth in the approved labeling. You administered six times the recommended dose and you did so with out 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) [21 U.S.C. § 360b(a)] of the Act and your use caused it to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.

You also received a letter dated April 11, 2007 from USDA/FSIS notifying you that tissue samples collected from a bob veal calf, [redacted] that you sold to [redacted] for slaughter for food, on February 26, 2007, contained drug residues above the tolerance level [redacted] sold the calf [redacted] to and it was slaughtered by on February 26, 2007. USDA/FSIS analysis of tissue samples from that animal identified the presence of 151.59 ppm Neomycin in the kidney tissue, 0.23 ppm Flunixin in the liver tissue, and 0.049 ppm Flunixin in the muscle tissue. A tolerance of 7.2 ppm has been established for residues of Neomycin in the kidney tissue of cattle, 21 C.F.R. § 556.430. No tolerance has been established for residues of Neomycin in the edible tissue of calves, because no withdrawal time has been established for preruminating calves; therefore, the drug is not to be used in calves that are to be processed for veal, 21 C.F.R. § 520.1484(d). The presence of these drugs in these amounts in edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii)[(21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.

Again, concerning this bob veal calf, our investigation 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 animals 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 maintained no health records on this calf except for the birth record, despite using Flunixin as "supportive therapy" in your calves. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C..§ 342(a)(4)] of the Act.

In addition, you adulterated Flunixin within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. As previously noted, "extralabel use," 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, and must comply with sections 512(a)(4) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and 21 C.F.R. Part 530.

Our investigation found that your extralabel use of Flunixin failed to comply with these requirements. For example, you administered the Flunixin to bob veal calves despite the label warning, "do not use in calves to be processed for veal," 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 53.0, the drug was unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and your use caused it to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.

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 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 can not 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 seat to William H. Sherer, Compliance Officer, U.S. Food and Drug Administration, P.0. Box 25087, 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.sherer@fda.hhs.gov.
 

Sincerely,

/S/

H. Thomas. Warwick
Denver District Director