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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Paul Bianchi, Inc. 1/15/13

  

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
 
Our Reference: 2938817
            WARNING LETTER
 
January 15, 2013
 
Paul P. Bianchi, President
Steve P. Bianchi, Vice President
Paul Bianchi, Inc.
15000 Highway 1
Valley Ford, California 94972
 
Dear Messrs. Bianchi:
 
On August 28, 29, and 31, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 15000 Highway 1, Valley Ford, 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)(oxytetracycline hydrochloride) Injectable, (b)(4) (amoxicillin) (b)(4) (cephapirin (b)(4) for Intramammary Infusion, (b)(4) (furosemide), (b)(4) (ceftiofur (b)(4). Specifically, our investigation revealed that you did not use (b)(4) (oxytetracycline hydrochloride) Injectable, (b)(4) (amoxicillin) (b)(4)(cephapirin (b)(4) for Intramammary Infusion, (b)(4)(furosemide), (b)(4)(ceftiofur (b)(4) as directed by their approved labeling or your servicing veterinarian’s prescription for use. 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)).  For your reference, we have enclosed a copy of 21 C.F.R. Part 530.
 
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 administer (b)(4) (oxytetracycline hydrochloride) Injectable, (b)(4), to your lactating dairy cows without following the approved animal class as stated in the approved labeling. Your extralabel use of (b)(4) (oxytetracycline hydrochloride) Injectable, (b)(4), was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). 
 
Our investigation found that you administer (b)(4) (amoxicillin) (b)(4), to your lactating dairy cows without following the withdrawal period prior to slaughter as stated in the approved labeling.  Your extralabel use of (b)(4) (amoxicillin) (b)(4), was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). 
 
Our investigation found that you administer (b)(4)(cephapirin (b)(4) for Intramammary Infusion, (b)(4), to your lactating dairy cows without following the dose limitation and the withdrawal period prior to slaughter as stated in the approved labeling.  Your extralabel use of (b)(4) (cephapirin (b)(4) for Intramammary Infusion, (b)(4), was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). 
 
Our investigation found that you administer (b)(4) (furosemide), (b)(4), to your lactating dairy cows without following the milk and meat withhold times as prescribed by your veterinarian. Your extralabel use of (b)(4)(furosemide), (b)(4), was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). 
 
Our investigation found that you administer (b)(4) (ceftiofur (b)(4), to your lactating dairy cows without following the meat withhold time prior to slaughter as prescribed by your servicing veterinarian. Your extralabel use of (b)(4) (ceftiofur (b)(4), was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). (b)(4) (ceftiofur (b)(4), is a cephalosporin that is prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(13).
 
Because your use of these drugs was not in conformance with their approved labeling or your servicing veterinarian’s prescription for use 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/
Barbara J. Cassens
District Director
San Francisco District
U. S. Food and Drug Administration