A Simoes Family Dairy 5/17/10

Department 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

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

W/L 17-10

May 17, 2010

Mr, Helio Simoes, Partner
A. Simoes Family Dairy
8625 E Riverside Drive
Ontario, California 91761-7202

Dear Mr. Simoes:

On March 9 and March 11, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8625 E Riverside Drive, Ontario, California 91761-7202. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation, You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

Specifically, our investigation revealed that on or about October 21, 2009, you sold a culled dairy cow, identified with back tag (b)(4) for slaughter as food. On or about October 22, 2009, (b)(4) , California, slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.15 parts per million (ppm) of penicillin residue in the kidney. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.510 (21 C.F.R. 556.510). Furthermore, our investigation determined that your firm's use of penicillin led to its presence in the animal that you offered for sale.

We also found that you adulterated the new animal drug, penicillin, Pro-Pen-G Injection (Penicillin G Procaine Injectable Suspension, NADA 065-505). Specifically, our investigation revealed that you did not use Pro-Pen-G Injection as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R, Part 530.10, 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 drug Pro-Pen-G Injection to dairy cows without following the indications for use as stated in the approved labeling. Your extralabel use of Pro-Pen-G Injection was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel uses of Pro-Pen-G Injection resulted in illegal drug residues in violation of 21 C.F.R. 530.11(d). Because your use of Pro-Pen-G Injection was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you
caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the 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 actions 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:

Alonza Cruse
District Director
U.S. Food and Drug Administration
19701 Fairchild
Irvine, California 92612

If you have any questions about this letter, please contact Raymond W. Brullo, Compliance Officer at (949) 608-2918 or Email at raymond.brullo@fda.hhs.gov.

Sincerely yours,

/s/

Alonza E. Cruse
District Director
Los Angeles District

 

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