De Jong Dairy 10/11/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
October 11, 2012
In reply, please refer to Warning Letter SEA 13-02
Nelva De Jong, Owner
De Jong Dairy
18731 SE 432nd Street
Enumclaw, Washington 98022
Dear Mrs. De Jong:
On August 22, 23, and 24, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 18731 SE 432nd
Street, Enumclaw, Washington. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov
We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about April 25, 2012, you sold a dairy cow, identified with ear tag (b)(4), for slaughter as food. On or about April 26, 2012, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.09 parts per million (ppm) of penicillin in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.510 (21 C.F.R. 556.510). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C 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. 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) of the FD&C Act, 21 U.S.C. § 342(a)(4).
We also found that you adulterated the new animal drug Pen-Aqueous (Penicillin G Procaine) Injectable Suspension, NADA 065-010. Specifically, our investigation revealed that you did not use Pen-Aqueous (Penicillin G Procaine) Injectable Suspension, NADA 065-010, as directed by its approved labeling. Use of this drug in this manner is an extralabel use, as defined at 21 C.F.R. 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered Pen-Aqueous (Penicillin G Procaine) Injectable Suspension, NADA 065-010, to your dairy cow without following the dose and dosage limitation per injection site as stated in the approved labeling. Your extra-label use of Pen-Aqueous (Penicillin G Procaine) Injectable Suspension, NADA 065-010, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Pen-Aqueous (Penicillin G Procaine) Injectable Suspension, NADA 065-010, resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. § 351(a)(5).
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 violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
Our investigation also revealed that on or March 12, 2012, you provided (b)(4), located in (b)(4), with a signed BSE & Drug Residues Affidavit and Declaration stating that you were not delivering livestock at (b)(4) with an illegal level of drug residues. This signed Affidavit and Declaration, which remains in full force and effect until revoked in writing by you and the revocation is delivered to (b)(4), covered the dairy cow, identified with ear tag (b)(4), which was found to contain a violative penicillin residue. Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
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 of receiving this letter, 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 Heidi Marks, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. If you have any questions about this letter, please contact Compliance Officer Marks at 425-302-0418 or by e-mail at email@example.com.
Charles M. Breen
Dr. Leonard Eldridge
WSDA Animal Health Services Division
P.O. Box 42560
1111 Washington St. W.
Olympia, WA 98501