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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Simoes & Sons Dairy, Inc. 10/19/11

  

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: 2939524
            WARNING LETTER
 
October 19, 2011
Joseph M. Simoes
President and Partner
Simoes and Sons Dairy, Inc.
12055 Bruceville Road
Elk Grove, California 95757
 
Dear Mr. Simoes:
 
On June 16 and 29, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 6900 Lambert Road, Elk Grove, 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
 
Our investigation found that you adulterated the new animal drugs chlortetracycline and sulfamethazine that were contained in the (b)(4) (Type B - Medicated Feed), (b)(4) (neomycin sulfate) Oral Solution, (b)(4), and (b)(4) (flunixin meglumine) Injectable Solution, (b)(4). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use, Title 21, Code of Federal Regulations, 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 the new animal drugs chlortetracycline and sulfamethazine that were contained in the (b)(4) (Type B - Medicated Feed) and (b)(4)(neomycin sulfate) Oral Solution, (b)(4), without following the indications and that you administered the new animal drug (b)(4) (flunixin meglumine) Injectable Solution, (b)(4), without following the route of administration as stated in their approved labeling. Your extralabel use of these products 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).
 
In addition, you adulterated the animal feed, (b)(4) (Type B - Medicated Feed), within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you failed to use this medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the indication as directed by the approved labeling 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.
 
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 Darlene Almogela, 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

 
cc:       
Lester M. Simoes, Partner
Leontina M. Simoes, Partner
7200 Lambert Road
Elk Grove, California 95757