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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Smith Incredibull Farms 29-Sep-05

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

Public Health Service
Food and Drug Administration


900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone : 215-597 4390



September 29, 2005


George A. Smith, Business Manager
Smith Incredibull Farms
2335 Oneida Valley Farms
North Washington, PA 16048

Dear Mr. Smith:

An investigation of your dairy farm and cattle operation located at 2335 Oneida Valley Road, North Washington, Pennsylvania was conducted by a representative of the U.S. Food and Drug Administration (FDA) on March 2 through March 7, 2005 with additional investigational follow-up at [redacted]on April 28 through May 3, 2005, and at [redacted] on May 23, 2005, confirmed that you offered an animal for sale for slaughter as food that was 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 [redacted] to become adulterated within the meaning of Section [501(a)(5)] [21 U.S.C. 351(a)(5)] and unsafe under section 512 of the Act [21 U.S.C 360b]. 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 or about December 13, 2004, you consigned a dairy cow, identified with ear tag, [redacted] and Farm tag [redacted] to [redacted] where it was subsequently identified with back tag number [redacted] for slaughter as food at [redacted] without informing the livestock aution of the medication status of this animal. On or about December 14, 2004 this animal was slaughtered at [redacted] at presence of United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of [redacted[ parts per million (ppm) [redacted] in the liver tissue and [redacted] ppm [redacted] in the muscle tissue of the animal. A tolerance of [redacted] ppm has been established for negligible residues of [redacted] in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Part [redacted] (21C.F.R. [redacted]. The presence of at a level above the tolerance in edible tissue(s) from this animal 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)].

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. Our investigatibn found that:

  • You lack an adequate system for assuring that animals have been treated only with drugs which have been approved for use in those species or that the extralabel use of such drugs is'otherwise in compliance with the extra label use provisions in 21 C.F.R. Part 530.

  • You lack an adequate system for assuring that drugs are used in a manner consistent with the directions contained in their labeling, or that the extralabel use of such drugs is otherwise in compliance with the extra labeIuse provisions in 21 C.F.R. Part 530.

  • You lack an adequate system for assuring 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.

  • You do not maintain adequate treatment records that include the amount of medication used for each animal, the route by which the medication was administered, how many times a day it was used, and who administered it.

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 [redacted] 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, must comply with sections 512(a)(4) and 512(a)(5) of the Act and 21 C.F.R. Part 530. Under 21 CFR 530.41(a)(9), only approved uses of [redacted] are permitted in lactating dairy cows; extralabel use is prohibited. You administered a [redacted] dose of [redacted] on two consecutive days for the treatment of mastitis; however, Di-[redacted] is approved only for [redacted] and [redacted]. Furthermore, your extralabel use resultedin. an illegal drug residue in violation of 21 CFR [redacted]. Because your extralabel use was not in compliance with extralabel use regulations, the drug is unsafe under section 512(a) of the Act [21 U.S.C. 360b(a)] and thus adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)].

In addition, for your information, for new animal drugs for which extralabel use is not prohibited, such use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. 21 CFR 530.10. A failure to meet these requirements renders the drug unsafe under section 512 of the Act and thus adulterated within the meaning of section 501(a)(5) of the Act.

Additionally, we are aware of the following violative tissue residue which USDA has traced back and assigned to your farm.

Tag Number Slaughter Date Slaughterhouse Residue/Tissue Tolerance

Back Tag# [redacted]

Ear Tag # [redacted]

Farm Tag# [redacted]





[redacted] ppm

[redacted] kidney

[redacted] ppm

We have recently become aware of a violative tissue residue which resulted in the issuance of a USDA Letter to you on April 22, 2005. This is the third violative tissue residue from your farm between May 2004 and April 2005. On or about March 29, 2005, you delivered: a dairy cow with back tag [redacted] ear tag [redacted]; farm tag [redacted] for sale for slaughter for human food. The cow was slaughtered for human food at [redacted] on or about March 29, 2005. USDA/FSIS analysis of the kidney tissue collected from the animal identified the presence of [redacted] ppm [redacted]. The tolerance for [redacted] in uncooked; edible bovine tissue [redacted] ppm per. 21 CFR Part, [redacted].

The above is riot 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 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 James C. Illuminati, Compliance. Officer, U.S. Food and Diug Administration, 2nd and Chestnut Street, Room 904 (HFR-CE140), Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Compliance Officer Illuminati at telephone number 215-717-3078 extension 4402, or by e-mail at James. llluminati@FDA.hhs.gov.


Thomas D. Gardine
District Director
Philadelphia District