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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Manuel and Maria Silva Dairy 1/30/14

  

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: 418298
 
WARNING LETTER
 
January 30, 2014
 
Manuel Silva, Co-Owner
Maria O. Silva, Co-Owner
Manuel and Maria Silva Dairy
15420 East Highway 4
Stockton, California 95215-9755
 
Dear Mr. and Mrs. Silva:
 
On November 25, 26, and 29, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 15420 East Highway 4, Stockton, 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) Dexamethasone Solution, ANADA (b)(4); (b)(4)(ceftiofur sodium), NADA (b)(4); (b)(4)Flunixin Injection (flunixin meglumine), ANADA (b)(4); (b)(4)(oxytetracycline), ANADA (b)(4); (b)(4) Penicillin Injectable (penicillin G procaine), ANADA (b)(4); and (b)(4)(enrofloxacin), NADA (b)(4).  Specifically, our investigation revealed that you did not use Dexamethasone, (b)(4), Flunixin, (b)(4), Penicillin G Procaine, and (b)(4) as directed by their prescription labels 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 Dexamethasone Solution (b)(4)(dexamethasone, ANADA (b)(4)), to your dairy cows without following the conditions for use and the dosage as stated in your servicing 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).
 
Our investigation found that you administered (b)(4)(ceftiofur sodium sterile powder, NADA (b)(4)) to a bob veal calf identified with back tag (b)(4) without following the conditions for use and slaughter withdrawal time as stated in your servicing veterinarian’s prescription. Our investigation also found that you administered (b)(4) to your lactating dairy cows without following the conditions for use and dosage administration as stated in your servicing veterinarian’s prescription. 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). (b)(4) is prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(13).
 
Our investigation found that you administered Flunixin Injection (flunixin meglumine, ANADA (b)(4)) to a bob veal calf identified with back tag (b)(4) without following the route of administration and slaughter withdrawal time as stated in your servicing veterinarian’s prescription. Our investigation also found you administered Flunixin to your lactating dairy cows and heifers without following the route of administration as stated in your servicing veterinarian’s prescription. Your extralabel use of Flunixin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). 
 
Our investigation found that you administered (b)(4)(oxytetracycline (b)(4), ANADA (b)(4)) to your lactating dairy cows without following the conditions for use, route of administration, dosage, and slaughter withholding times as stated in the approved labeling. Our investigation also found that you administered (b)(4) to your heifers without following the route of administration and slaughter withholding times as stated 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).
 
Our investigation also found that you administered Penicillin Injectable (penicillin G procaine, NADA (b)(4)) to your fresh dairy cows without following the dosage, dosage per injection site, and the milk and meat withholding times as stated in your servicing veterinarian’s prescription.  Your extralabel use of Penicillin was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).
 
Our investigation also found that you administered (b)(4)(enrofloxacin, NADA (b)(4)) to your heifer calves without following the route of administration and duration of treatment as stated in your servicing veterinarian’s prescription. 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 these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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 Lawton W. Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, at 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