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U.S. Department of Health and Human Services

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Enforcement Actions

Mario M. Simoes Dairy #2 29-Dec-03

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

Public Health Service
Food and Drug Administration

 

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94602-7070
Telephone: 510/337-6700


 

VIA FEDERAL EXPRESS
Our Reference: 1000123908

December 29, 2003

Mr. & Mrs. Mario Simoes Jr, Owners
Mario M. Simoes Dairy #2
13440 Road 136
Tipton, California 93272-9717

WARNING LETTER

Dear Mr. & Mrs. Simoes:

An investigation of your dairy operation in Tulare, California conducted by our investigators on November 12, 13, and 14 2403, confirmed that you offered an animal for sale for slaughter as food in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act(the Act), 21 U.S.C. §§ 342(a)(2)(C)(ii) and 342(a)(4), and that you have caused animal drugs to become adulterated within the meaning of Section 501(a)(5) of the Act, 2) U.S.C. § 351.

On or about June 27, 2003, you consigned a cow(identified by United States Department of Agriculture (USDA) laboratory report number 431594) to be slaughtered for human food at [redacted]. USDA analysis of tissue samples collected from that animal identified the presence of 0.95 parts per million (ppm) gentunicin in the kidney. This level exceeds the 0.4 ppm tolerance that has been established for residues of gentannicin in cattle kidney (Title 21, Code of Federal Regulations, Section 556.300).The presence of gentamicin at these levels in edible tissues from this animal causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.

A Food is adulterated under Section 402(a)(4)of the Act "if it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health." As it applies in this case,"insanitary conditions" means that you hold animals which are ultimately offered for sale for slaughter as food under conditions which are so inadequate that medicated animals bearing possibly harmful drug residues are likely to enter the food supply. For example, our investigators observed the following:

1. Your firm fails to maintain an adequate system for assuring that drugs are used in a manner consistent with the directions contained in their labeling or in a written prescription from your veterinarian, specifically,

. Gentairsicin Sulfate
. {redacted] (Oxytetracycline Hydrochloride)
. [redacted] brand Flunixin Meglumine
. [redacted] brand Dexamethasone Solution

2. Your firm fails to maintain a complete, written, medication treatment record system for your airmails that includes all treatments, the amount of drug administered, the route of administration, and the person who administered the drug.

3. Your firm fails to review treatment records prior to offering an animal for slaughter for human food to assure that appropriate withdrawal times for drugs have been observed.

4. Your firm fails to maintain a drug inventory/accountability system.

Our investigator also observed that you have adulterated the drug Gentamicin Sulfate and are adulterating the drugs [redacted] (Oxytetracycline Hydrochloride), [redacted] brand Flunixin Meglumine, [redacted] brand Dexamethasone Solution, and [redacted] (Sodium Cloxacillin) that your firm uses on cattle within the meaning of Section 501(a)(5) of the Act when you fail(ed) to use the drugs in conformance with their approved labeling or in accordance with a written prescription from your veterinarian.

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 assuring that your overall operation and the foods you distribute are in compliance with the law.

You should take prompt action to correct the above violations and to establish procedures whereby, such violations do not recur. Failure to do so may result in regulatory action, such as seeking a seizure and/or injunction, without further notice.

It is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you caused the adulteration of an animal that was sold and subseqneatly offered for sale to a slaughter house that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.

You should notify this office in writing within 15 working days of the date you receive this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include each step being taken, that has been taken, or that will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, 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 response should be directed to: Ms. Harumi Kishide, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070.

If you have any questions regarding any issue in this letter, please contact Ms. Kishida at (510)337-6824.

Sincerely,

/s/

Dennnis K. Linsley
District Director
San Francisco District