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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Simco Dairy 14-Nov-07

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

Public Health Service
Food and Drug Administration

 

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421

Telephone: 425-486-8788
FAX: 425-483-4996


 

November 14, 2007

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 

In reply refer to Warning Letter SEA 08-03

Daniel S. VanGrouw, Owner
Sam L. Adams, Manager
Simco Dairy
13800 Simco Road
Boise, Idaho 83716-3449

WARNING LETTER

Dear Messrs. VanGrouw and Adams:

An investigation of your dairy operation located at 13800 Simco Road, Boise, Idaho, conducted by a representative of the U.S. Food and Drug Administration (FDA) on August 28, 30, and 31, 2007, 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 investigation also revealed that you caused the new animal drugs penicillin and flunixin to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] of the Act and unsafe under section 512 [21 U.S.C. 360b] 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 or about February 6, 2007, you sold a cow, identified with ear tag [redacted] and subsequent back tag [redacted] for slaughter as food at [redacted]. On or about February 7, 2007, this animal was slaughtered 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 penicillin at 1.36 parts per million (ppm) in the kidney and 0.07 ppm in the liver. 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).

On or about March 6, 2007, you sold a cow, identified with ear tag [redacted] and subsequent back tag [redacted] for slaughter as food [redacted]. On or about March 9, 2007, this animal was slaughtered at [redacted] at USDA/FSIS analysis of tissue collected from that animal identified the presence of flunixin at 0.163 ppm in the liver. A tolerance of 0.125 ppm has been established for residues of flunixin in the liver of cattle, as codified in 21 C.F.R. 556.286(b)(1)(i).

On or about May 30, 2007, you sold a cow, identified with ear tag [redacted] and subsequent back tag [redacted] for slaughter as food at [redacted]. On or about May 31, 2007, this animal was slaughtered at [redacted] USDA/FSIS analysis of tissue collected from that animal identified the presence of penicillin at 0.29 ppm in the kidney.

On or about June 25, 2007, you sold a cow, identified with ear tag [redacted] and subsequent back tag [redacted] for slaughter as food at [redacted]. On or about June 27, 2007, this animal was slaughtered at [redacted] USDA/FSIS analysis of tissue ,collected from that animal identified the presence of penicillin at 1.34 ppm in the kidney and 0.09 ppm in the liver.

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 the new animal drugs penicillin and 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 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. Our investigation found that your extralabel use of penicillin and flunixin failed to comply with these requirements. For example, you administered penicillin without following the dosage level and the directions for administering the drug set forth in the approved labeling, and you did so without the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). In addition, you administered flunixin without adhering to the route of administration specified by the approved labeling 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 these drugs resulted in illegal drug residues, in violation of 21 C.F.R. 530,11(d). Because your extralabel use of these drugs was not in compliance with 21 C.F.R. Part 530, the drugs were unsafe under section 512(a) [21 U.S.C. 360b(a)] of the Act, and your use caused the drugs 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 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 the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Mr. Donovan at (425)483-4906.

Sincerely,

/S/

Charles M. Breen
District Director

(w/copy of FDA-483):

CC: FSIS District Office Western Region
Attn: Regional Manager
620 Central Ave. Building 2B, Alameda, California 94501

Idaho State Department of Agriculture, Division of Animal Industries
P.O. Box 7249, Boise, Idaho 83707