Inspections, Compliance, Enforcement, and Criminal Investigations
De Vries Dairy 26-Feb-07
Department of Health and Human Services
Public Health Service
Seattle District Office
February 26, 2007
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 07-10
Fred R. De Vries, Co-owner
Danielle De Vries, Co-owner
Alice DeVries, Co-owner
De Vries Dairy
3533 Thillberg Road
Mount Vernon, Washington 98273-8015
Dear Mr. Fred De Vries, Ms. Alice DeVries, and Ms. Danielle
An investigation of your dairy operation located at 12797 Thillberg Road, Mount Vernon, Washington, conducted by a representative of the U.S. Food and Drug Administration (FDA) on December 12, 2006, and January 7, 2007, 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, penicillin G procaine, to become 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 the FDA's web page at www.fda.gov.
On or about September 26, 2006, you delivered a dairy cow for slaughter as food to [redacted] a cattle hauler, who, on that same day, delivered the animal to [redacted] where it was identified with [redacted] Back Tag Number 065. On September 27, 2006, that animal was sold and shipped to [redacted] where was it subsequently slaughtered on September 28, 2006. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.58 parts per million (ppm) of penicillin in the kidney tissue and 0.16 ppm penicillin in the liver 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 penicillin above the established tolerance level 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 any treatment/medication records for the animals you were medicating to permit you to systematically review those medication/treatment records prior to delivering the referenced animal for slaughter as food. 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 penicillin G procaine 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 with the context of a valid veterinarian/client/patient relationship. The extralebel 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 G procaine failed to comply with these requirements.
For example, you administered the penicillin G procaine without following the dosage level of treatment, duration of treatment, or the methods for injecting 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). 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 CFR 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.
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 about this letter, please contract Mr. Donovan at (425) 483-4906.
Charles M. Breen
(w/copy of FDA-483):
CC: Dr. Julie Cornett, USDA-FSIS, Technical Service Center
Landmark Center, Suite 300,
1299 Farnam Street
Omaha, NE 68102
Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560