Inspections, Compliance, Enforcement, and Criminal Investigations
Meadowbrook Dairy 30-May-06
Department of Health and Human Services
Public Health Service
Los Angeles District
May 30, 2006
RETURN RECEIPT REQUESTED
Edward Imsand, Owner
PO Box 294370
Phelan, CA 92329
Dear Mr. Imsand:
Our records reflect that you are the owner of Meadowbrook Dairy located at 17900 Sheep Creek Road, El Mirage, CA . An investigation of your dairy operation conducted by a representative of the U.S. Food and Drug Administration (FDA) on March 13-21, 2006, 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 inspection also revealed that you caused the new animal drugs flunixin and injectable penicillin G procaine 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 January 20, 2006, you sold a culled dairy cow, identified with backtag number [redacted] (ear tag number 840), for slaughter as food to [redacted]. On or about that same date, 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 flunixin in the liver at 11.049 parts per million (ppm). A tolerance of 0.125 ppm has been established for residues of flunixin in the liver of cattle as codified in Title 21, Code of Federal Regulations, Section 556.286 [21 CFR 556.286]. The presence of this drug in the edible tissue 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. For example, 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. 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 flunixin and injectable penicillin G procaine within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)] when you failed to use the drugs in conformance with their approved labeling. "Extra-label 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 extra-label use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. 360b(a)(4) and (a)(5)] and 21 C.F.R. Part 530. Our investigation found that your extra-label use of flunixin and injectable penicillin G procaine failed to comply with these requirements. For example, you administered flunixin without following the withdrawal period 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 extra-label use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). You administered injectable penicillin G procaine in dairy cattle without following the dosage level set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, also in violation of 21 C.F.R. 530.11(a). Because your extra-label use of these drugs was not in compliance with 21 C.F.R. Part 530, the drugs were unsafe under section 512(a) of the Act [21 U.S.C. 360b(a)] and your use caused them to be 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 are 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:
Pamela B.Schweikert, Director
U.S. Food and Drug Administration
Irvine, CA 92612.
If you have any questions about this letter, please contact Compliance Officer Barbara Rincon at (949) 608-4439.
Alonz1a E. Cruse