Inspections, Compliance, Enforcement, and Criminal Investigations
Rockhill Dairy LLC 22-Jun-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Denver District Office
Bldg. 20-Derwer Federal Center
P.O. B0X 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
June 22, 2001
RETURN RECEIPT REQUESTEDMr. Carlos Villalpando
Rockhill Dairy LLC
104 Ojibwa Road
Dexter, New Mexico 88230
Ref. #: DEN-01-37
Dear Mr. Villalpando:
Consumer Safety Officer Betty K. Baxter conducted an investigation at your dairy farm located in Dexter, New Mexico on April 18 & 19,2001. The inspection 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).
On November 02, 2000, you offered a cow for slaughter as human food to [redacted]. This cow, identified as USDA case number 99-0315-NM, was found with illegal levels pf drug residue.
Specifically, USDA analysis of tissue samples collected from cow #635, on November 02,2000, identified the presence of penicillin residue of 3.14 ppm in the kidney, 0.89 ppm in the liver and 0.16 ppm in the muscle. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of beef cows in Title 21 Code of Federal Regulations Part 556.510 (21 CFR 556.510).
The presence of this drug at the levels found in edible tissue horn this animal causes the food to be adulterated within the meaning of section 402(a) (2)( C)(ii) of the Act.
Our investigation found that you hold animals under conditions which are inadequate to prevent medicated animals bearing potentially harmful drug residues from entering the food supply. For example, you lack an adequate system for assuring that animals medicated by you have been withheld born slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act.
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 and permanent action to correct the above violations and to establish procedures whereby such violations do not recur. This is the second Warning Letter issued to you for tissue residue violations. You were issued a Warning Letter on January 24, 2000 for illegal gentamicin residues in one of your cows. We consider this second violation to be a very serious matter. Failure to make lasting corrections will result in regulatory action without further notice including seizure, prosecution, and/or injunction.
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 subsequently offered for sale to a slaughterhouse 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 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 will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 30 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 sent to Tom Warwick, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado, 80225-0087. He maybe reached at (303) 236-3054 if you have any questions about this matter.
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