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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Vaqueria Gustavo Toledo 28-Feb-05

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

Public Health Service
Food and Drug Administration

 

466 Femandez Juncos Avenue
San Juan, Puerto Rico 00901
Telephone. 787-474-9510
FAX: 787-729-6868


 


February 28, 2005

WARNING LETTER
SJN-05-04

CERTIFIED MAIL,
RETURN RECEIPT REOUESTED

Mr. Gustavo Toledo Toledo
Owner
Vaqueria Gustavo Toledo
P.O. Box 1138, Sector Naranjito
Hatillo, Puerto Rico 00659

Dear Mr. Toledo:

On September 28, 2004 to October 05, 2004, an investigator from the Food and Drug Administration conducted an investigation at your dairy facility located at road number 491, km. 1 sector Naranjito, Hatillo, Puerto Rico 00659. This investigation confirmed that you offered five (5) animals 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) . The investigation also revealed that you caused an animal drug to be unsafe under Section 512(a) of the Act and adulterated within the meaning of Section 501(a)(5) of the Act, because the drug was used in a manner that does not conform with its approved use or the regulations for Extralabel Drug Use in Animals at Title 21, Code of Federal Regulations, Part 530 (21 CFR 530).

These animals were sold by an intermediary for slaughter as human food at [redacted] a slaughterhouse located at [redacted] United States Department of Agriculture (USDA) analysis of tissue samples revealed the presence of neomycin residues in kidney in each of the five animals as follows:

Retain Tag #Date SlaughteredResidueAmount in ppmTissue
[redacted]6/22/04[redacted][redacted]Kidney
[redacted]6/22/04[redacted][redacted]Kidney
[redacted]6/22/04[redacted][redacted]Kidney
[redacted]5/26/04[redacted][redacted]Kidney
[redacted]5/26/04[redacted][redacted]Kidney

The tolerance for [redacted] in the [redacted] of the cattle kidney (21 CFR 556.430). The presence of this drug in edible tissues at the reported levels causes the food to be adulterated within the meaning of 402(a)(2)(C)(ii) of the Act.

Our investigation also found that you hold animals under conditions which are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you lack an adequate system to assure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially harmful residues of drugs from edible tissues. In addition, the treatment records do not identify the drug used, date the drug was administered, the route of administration, dosage administered, duration of treatment, and the withdrawal time required prior to slaughter. Foods from animals held under such conditions are considered adulterated within the meaning of Section 402(a) (4) of the Act.

In addition, you adulterated the drug neomycin within the meaning of Section 501(a)(5) of the Act when you used it at a dosage level that is contrary to the product's approval . The extralabel use of approved animal drugs is allowed if the use complies with Sections 512(a)(4) of the Act and 21 CFR Part 530. You administered neomycin without the supervision of a licensed veterinarian, 21 CFR 530.11(a), and your use of neomycin resulted in the presence of drug residue in edible tissue that might present a risk to public health, 21 CFR 530.11(c).

We note that since the inspection, additional illegal residues have been found in cows you own. On August 16, 2004, USDA collected a sample from a dairy cow that tested positive for the presence of [redacted]. The tolerance for penicillin is 0.05 ppm in the uncooked edible tissues of cattle. On November 5, 2004, USDA collected a sample from a bob veal calf that tested positive for the presence of [redacted]. No tolerance has been established for use of this drug in calves.

This letter 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 comply 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 without further notice, such as seizure and/or injunction.

Please notify this office in writing within 15 working days of the steps you have taken to bring your firm into compliance with the law. Your response should include each step being 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 written reply to these concerns should be directed to` the Food and Drug Administration, attention: Carlos A. Medina, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any concerns about this letter, please contact Mr. Medina at (787) 474-9538.

Sincerely,

/S/

Donald Voeller
District Director