Inspections, Compliance, Enforcement, and Criminal Investigations
Jose Luis Perez Padin Farm 2/11/05
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
468 Fernandez Juncos Avenue
February 11, 2005
RETURN RECEIPT REQUESTED
Mr. Jose Luis Perez Padin
Mr. Jose Luis Perez Rosado
Jose Luis Perez Padin Farm
P.O. Box 862
Camuy, Puerto Rico 00627
Dear Mr. Perez Padin and Perez Rosado:
On November 09-15, 2004, an investigator from the Food and Drug Administration conducted an inspection at your dairy facility located at road number 119, km. 11.5 sector La Ciena, Camuy, Puerto Rico. This inspection confirmed that you offered an animal for sale for food that was adulterated within the meaning of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it contains a new animal drug which is unsafe within the meaning of Section 512(a) of the Act. You also caused the adulteration of a new animal drug per Section 501(a)(5) of the Act because the drug was used in a manner that does not conform with its approved use or extralabel use regulations, therefore making it unsafe within the meaning of Section 512 of the Act.
On or about August 24, 2004, you offered for sale an adult dairy cow identified with ear tag number (b)(4) for slaughter as human food. This cow was sold, through an intermediary, to (b)(4) Slaughterhouse located at road number (b)(4) intersection with road number sector (b)(4) USDA analysis of tissue samples collected from this animal confirmed the presence of gentamicin residues in the amount of 1.50 parts per million (ppm) in the kidney.
Gentamicin is not approved for use in cattle and no tolerance has been established for residues of gentamicin in edible tissues of cattle. The presence of this drug in edible tissues of this animal causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.
A food is also 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. You lack a system for assuring animals medicated on your farm have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous drug residues from edible tissues. For example, our investigator noted that you do not identify treated animals. In addition, there are no records for the treatment of the above cow with gentamicin. Foods from animals held under such conditions are adulterated under Section 402(a)(4) of the Act.
You also caused the adulteration of the drug gentamicin sulfate within the meaning of Section 501(a)(5) of the Act when you used this drug in dairy cattle, a species for which it is not approved. The extralabel use of an approved animal drug is allowed if the use complies with Section 512(a)(4) of the Act and 21 CFR Part 530. However, your use of the drug was not in compliance with the extralabel use regulations because you administered it without the benefit of a valid veterinarian client-patient relationship. 21 CFR 530.10(a). In addition. your use of gentamicin resulted in the presence of drug residue in edible tissue that may present a risk to public health. 21 CPR 530.11(c). This extralabel use caused the animal drug to be unsafe within the meaning of Section 512(a) of the Act, and thus adulterated within the meaning of Section 501(a)(5) of the Act.
The above is not intended to be an all-inclusive list of violations. As a producer of dairy cows that are offered for use as food, you are responsible for assuring that your overall operation and the food you distribute are in compliance with the law. You should take prompt action to correct these violations and to establish procedures to prevent recurrence. Failure to promptly correct these violations may result in regulatory sanctions without further notice. These sanctions include. but are not limited to, seizure and/or injunction. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies.
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 issue in this letter, please contact Mr. Medina at (787) 474-9538.
Donald J. Voeller
San Juan District