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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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TH Mello and Sons Dairy 11/19/12


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


Our Reference: 3008365340
            WARNING LETTER
November 19, 2012
Tony Mello, Co-owner
Helen M. Mello, Co-owner
TH Mello and Sons Dairy
9415 Orr Road
Galt, California 95632
Dear Mrs. and Mr. Mello:
On September 25, 26, and October 2, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 10090 Kost Road, Galt, 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) Sulfadimethoxine Soluble Powder (Sulfadimethoxine Soluble Powder) (b)(4) and (b)(4) (Flunixin Meglumine Injectable Solution) (b)(4). Specifically, our investigation revealed that you did not use sulfadimethoxine soluble powder and flunixin meglumine injectable solution as directed by their 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 sulfadimethoxine soluble powder (b)(4) Sulfadimethoxine Soluble Powder) to one of your lactating dairy cows without following the indications for use and class of animal as stated in the approved labeling.  Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9).  
Our investigation also found that you administered flunixin meglumine injectable solution (b)(4) to your lactating dairy cows without following the dosage and conditions for use as stated in the approved labeling and your veterinarian’s prescribed instructions. Your extralabel use of flunixin meglumine injectable solution (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.
Barbara J. Cassens
District Director
San Francisco District
U. S. Food and Drug Administration