Schumacher's 08-Dec-06

December 8, 2006

WARNING LETTER NYK 2007-06

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

Jerry Schumacher, Owner
Schumacher's
396 Starr Road
Wyoming, New York 14591

Dear Mr. Schumacher:

An inspection of your dairy farm operation located at 384 Starr Road, Wyoming, New York, conducted by a representative of the U.S. Food and Drug Administration (FDA) on May 2-24,2006, and July 18, 2006, confirmed that you offered two 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, Albon® (sulfadimethoxine) bolus, NADA 31-715, and Agri-Cillin (penicillin G procaine injectable suspension U.S. P.), NADA 65-010, to be unsafe under section 512 [21 U.S. .C. § 360b] 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 FDA's web page at www.fda.gov.

On or about January 19, 2006, you delivered a dairy cow, identified with your farm tag P8 for slaughter as food to [redacted], where it was additionally identified with tags [redacted] and [redacted] before it was purchased for slaughter by [redacted]. On or about January 20, 2006, the cow was slaughtered as food at [redacted]. United States Department of Agriculture, Food Safety and Inspection Service (USDA~/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.31 ppm sulfadimethoxine in liver tissue. A tolerance of 0.1 part per million (ppm) is established for residues of sulfadimethoxine in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Part 556.640(b) [21 C.F.R. 556.640(b)(1)]. The presence of this drug in this amount in the uncooked edible tissues of 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 .

On or about March 2, 2006, you delivered a dairy cow to [redacted], where it was identified with tags [redacted]and [redacted] before it was purchased for slaughter by [redacted].On or about March 6, 2006, the cow was slaughtered as food at [redacted]. USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 0.13 ppm penicillin in kidney tissue. A tolerance of 0.05 ppm is established for residues of penicillin in the uncooked edible tissues of cattle as codified in 21 C.F.R. 556.510(a). The presence of this drug in this amount in the uncooked edible tissues of 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 any written treatment records which document the identity of the animal, treatment dates, drugs administered, dosage administered, route of administration, and withdrawal times for milk and beef. 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 Albon® (sulfadimethoxine), NADA 31-715, and Agri-Cillin (penicillin G procaine injectable suspension U.S. P.), NADA 65-010, within the meaning of section 501 (a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use the drugs in conformance with their 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.

The extralabel use of sulfadimethoxine is prohibited, see 21 C.F.R. 530.41(a)(9). Our investigation found that your use of Albon® (sulfadimethoxine), NADA 31-715 was a prohibited extralabel use, in that you failed to follow the label dosage level and duration of treatment set forth in the approved labeling for the drug. Furthermore, your extralabel use of Albon® (sulfadimethoxine), NADA 31-715, 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, your use caused the drug to be unsafe under section 5i2(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.

In addition, your extralabel use of Agri-Cillin (penicillin G procaine injectable suspension U.S. P.), NADA 65-010, failed to comply with 21 C .F. R. Part 530. For example, you administered Agric (penicillin G procaine injectable suspension U.S. P.), NADA 65-010, without following the labeled dosage level and duration of treatment set forth in the approved labeling for the drug 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 of this drug 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, your use caused the drug to be 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.

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 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 response should be sent to Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A. Clark at (716) 551-4461, extension 3168.

Sincerely yours,

/S/

Otto D. Vitillo
Director, New York District