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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Luis Dairy 11/1/13

  

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

Public Health Service
Food and Drug Administration
 
San Francisco District
Pacific Region
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
 
Telephone:    510-337-6700
FAX:    510-337-6701

 

UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
CMS: 412442
 
 WARNING LETTER
 
November 1, 2013
 
Luis S. Luis, Owner
Teresa Luis, Owner
Luis Dairy
1692 Mahogany Drive
Los Banos, California 93635
 
Dear Mr. and Mrs. Luis:
 
On August 13, 14, and 16, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 19566 Charleston Road, Los Banos, California. 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 adulterated the new animal drugs (b)(4) (penicillin-dihydrostreptomycin (b)(4) (penicillin G procaine injectable suspension), (b)(4) (oxytetracycline hydrochloride injection), (b)(4); Dexamethasone, (b)(4) (florfenicol), (b)(4).  Specifically, our investigation revealed that you did not use (b)(4) , Dexamethasone, and (b)(4) as directed by their prescription or approved labeling. Use of these drugs in this manner is an extralabel use. See Title 21, Code of Federal Regulations (C.F.R.), Section 530.3(a) (21 C.F.R. 530.3(a)). We have enclosed a copy for your reference.
 
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 (b)(4), to your dairy cows, and the drug subsequently went into your cow’s colostrum.  You allowed your bob veal calves access to these treated dairy cows without following the labeled prohibition to not use as food a cow’s colostrum for 96 hours (eight milkings) after calving as stated in the approved labeling. Your extralabel use of (b)(4) was in or on feed, in violation of 21 C.F.R. 530.11(b).  Because your use of this drug was not in conformance with the approved labeling and your servicing veterinarian’s prescription and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
 
In addition, you adulterated your dairy cow’s medicated colostrum within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you allowed your bob veal calves to ingest this medicated feed. The feeding of this medicated feed (colostrum) without following its prohibited use as directed by the approved labeling of (b)(4), caused this medicated feed to be unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Section 512 of the FD&C Act, 21 U.S.C. § 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feeds.
 
Our investigation found that you administered (b)(4) to your lactating dairy cows without following the condition for use, dosage, and dosage per injection site as directed in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of this drug was not in conformance with the approved label directions and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
 
Our investigation found that you administered (b)(4) to your lactating dairy cows without following the class of animal as directed in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of this drug was not in conformance with the approved label directions and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
 
Our investigation found that you administered Dexamethasone to your heifers without following the dosage as directed by your veterinarian’s prescription. Your extralabel use of Dexamethasone was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of this drug was not in conformance with the approved label directions and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
 
Our investigation found that you administered (b)(4) to your calves and heifers without following the duration of treatment and slaughter withdrawal time as directed in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of this drug was not in conformance with the approved label directions and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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.
 
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 Mr. Lawton W. Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 1114 or via e-mail at Karen.Robles@fda.hhs.gov. 
 
Sincerely,
/S/ 
Kathleen M. Lewis, J.D.
District Director
San Francisco District
U. S. Food and Drug Administration