Inspections, Compliance, Enforcement, and Criminal Investigations
Pyrenees Dairy 14-Mar-08
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REOUESTED
March 14, 2008
RETURN RECEIPT REQUESTED
Mr. Frank Arburua, Co-owner
Mrs. Mary Arburua, Co-owner
6274 Carter Court
Chino, California 91708-9239
Dear Mr. and Mrs. Arburua:
An inspection of your dairy operation located at 8340 Pine Avenue, Chino, CA 91710, conducted by a representative of the U.S. Food and Drug Administration (FDA) on December 18, 2007 and January 3, 2008, 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 drug, Pen-Aqueous® penicillin G procaine, to become 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.
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 the dates of March 6, 2007, May 3, 2007, and July 23, 2007, you sold a cow each day, identified with ear tag numbers [redacted] and [redacted] respectively, for slaughter as food at [redacted]. On or about the same date as the cows were sold, these animals were slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from each of these animals identified the presence of penicillin as follows:
A tolerance of 0.05ppm has been established for residues of penicillin in the 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 this drug in these amounts in edible tissues from each of these 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 animal treatment records that assure drugs have been used only as directed and that appropriate withdrawal times have been observed prior to offering an animal for slaughter for human 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 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 extra-label use of penicillin G procaine failed to comply with these requirements.
For example, you administered the penicillin G procaine without following the dosage level 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 C.F.R. 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 as 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, Compliance Branch, U.S. Food and Drug Administration, Los Angeles District Office, 19701 Fairchild Road, Irvine, CA 91612. If you have any questions about this letter, please contact Compliance Officer Robert B. McNab at (949) 608-4409.
Alonza E. Cruse
Los Angeles District
cc: Mr. Louis R. Arburua, Manager
6274 Carter Ct.
Chino, CA 91708
State Regulatory Authority
Producer's Servicing Veterinarian
FSIS District Office
FSIS Policy Development Division