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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Vander Werff Rigg Dairy 16-Jan-07

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

Public Health Service
Food and Drug Administration

 

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 5510/337-6700


 


VIA FEDERAL EXPRESS

Our Reference: 2939469

January 16, 2007

Caroline N. Rigg, Partner
Peter C. V andererff, Co-owner
Vander Werff Rigg Dairy
24567 Lone Tree Road
Escalon, California 95320

WARNING LETTER

Dear Ms. Rigg and Mr. Vander Werff

An inspection of dairy operation located at 24567 Lone Tree Escalon, California, conducted by representatives of the U.S. Food & Drug Administration (FDA) on August 22, 23 and 24, 2006, 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 medicated calf formula containing the new animal drugs oxytetracycline HCL and neomycin to become unsafe within the meaning of section 512 [21 U.S.C. § 360(b)] the Act and adulterated within the meaning of section 501(a)(6) [21 U.S.C. §351(a)(6)] of the Act. Furthermore, you caused the new animal drug penicillin G procaine to become unsafe within meaning of section [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 the Act and its regulations on the internet through links on the FDA's web page at www.fda.gov.

On or about April 21, 2006, you consigned a bull calf, identified with back tag number [redacted] to [redacted] in [redacted]. On April 21,2006, this calf was sold through the sales yard and subsequently custom slaughtered for [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 neomycin in the kidney at 22.76 parts per million (ppm). A tolerance level for residues of neomycin has been established for the kidney of cattle at 7.2 ppm as codified in Title 21, Code of Federal Regulations, Section 556.430 (21 C.F.R. § 556.430).

The presence of this drug in the kidney of this calf in this amount 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 inspection 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 treatment records and you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals. 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 medicated calf formula containing the drugs oxytetracycline HCL and neomycin [redacted] brand [redacted] within the meaning of section 501(a)(6) [21 U.S.C. § 351(a)(6)] 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. However, the extralabel use of medicated feed is not permitted, see section 512(a)(4) [21 U.S.C. § 360b(a)(4)]. Therefore, your extralabel use of this drug caused it 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)(6) [21 U.S.C. §351(a)(6)] of the Act.

Furthermore, our inspection revealed you routinely administer [redacted]'s of penicillin G procaine [redacted] to your dairy cows. Label directions for penicillin G procaine [redacted] specify a dosage of 1cc per 100 lbs of bodyweight and no more than 10cc per injection site. Your extralabel use, however, did not comply with the applicable requirements because, for example, your extralabel use was not under 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, your use caused it to be 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.

We also noted during our inspection that you adulterated the soluble powder form of the drug sulfadimethoxine [redacted] 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 . The extralabel use of sulfadimethoxine is prohibited under 21 C.F.R. 530.41(9). You administered the drug sulfadimethoxine to your adult dairy cows without following the indications for use set forth in the approved labeling. The labeling for this drug indicates it is for the treatment of chickens, turkeys, dairy calves, dairy heifers, and beef cattle. Because the extralabel use of this drug is prohibited under 21 C.F.R. § 530.41(9), your use caused it to be unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act.

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.

Your firm has a history of offering cattle for sale for human food use that contain above tolerance levels of antibiotic residues. According to FDA's reports, between June 28 and October 21, 1988, your firm delivered [redacted] calves that were found CAST (Calf Antibiotic Sulfa Test) positive by USDA analysis due to the possible presence of violative levels of antibiotics. As a follow up to these calves, an inspection was conducted of the dairy on February 24, 1989. According to USDA reports, during the period of January 3, 1989, through April 21, 2006, your firm delivered [redacted] additional CAST+ calves, [redacted] calf with a penicillin residue, [redacted] calf with a tetracycline residue, [redacted] with a penicillin residue, and the most recent residue involves a calf with a neomycin residue.

FDA conducted another inspection of the dairy on May 16, 1995, which resulted in a Warning Letter dated June 8, 1995. In addition, FDA conducted an inspection of the dairy on January 7, 1997, which resulted in a Warning Letter dated January 28, 1997. During each of the inspections and subsequent Warning Letters, the firm was warned that it is illegal to market animals with above-tolerance levels of antibiotics in the tissues of dairy animals.

Moreover, on or about January 16, 2006, you consigned a dairy cow, identified with back tag number [redacted] to [redacted] in [redacted] On January 17, 2006, this dairy cow slaughtered. USDA/FSIS analysis of tissue samples collected from that animal identified the presence of penicillin in the kidney at 0.41 parts per million (ppm). A tolerance level for residues of penicillin has been established for the uncooked edible tissues of cattle at 0.05 ppm as codified in 21 C.F.R. § 556.510).

We have enclosed an amended version of the FDA-483 issued to you at the close of our inspection.

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 response should be directed to Karen L. Robles, Consumer Safety Officer, Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502, If you have any questions regarding this letter, please contact Karen Robles at (9i6) 930-3674, ext. 14.

Sincerely,

/S/

Barbara J. Cassens
District Director
San Francisco District