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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Souza Dairy 12/11/12

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
                                                                       
December 11, 2012
WL   09-13
Mr. Frank M. Souza, Co-owner
Mr. Danny F. Souza, Co-owner
Mr. John F. Souza, Co-owner
 
c/o:
Ms. Alice M. Souza, Manager
Souza Dairy
16185 Euclid Avenue,
Chino, California 91708
 
Dear Messrs.:
 
On August 14-15, August 27 and October 9-10, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 16185 Euclid Avenue, Chino, 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 drug (b)(4) (neomycin sulfate) (b)(4). Specifically, our investigation revealed that you did not use (b)(4) as directed by its approved labeling. Use of this drug 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)). 
 
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 veal calves identified with ear tags (b)(4) and (b)(4) without following the animal class 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).
 
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:
 
Blake Bevill
Director of Compliance
U.S. Food and Drug Administration
19701 Fairchild
Irvine, California 92612
 
If you have any questions about this letter, please contact Compliance Officer William S. Vitale at (949) 608-2919.
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
 
 
Cc:
 
Ms. Ingeborg Small, Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS 7602
P.O. Box 997435
Sacramento, California 95899-7435