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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

John, David E 09-Feb-07

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

Public Health Service
Food and Drug Administration

 

New York District
300 Pearl Street, Suite 100
Buffalo, NY 14202


 


February 9, 2007

WARNING LETTER NYK 2OO7-08

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

David E. Johnson
d/b/a Joleanna Holsteins
331 Covered Bridge Rd.
Unadilla, New York 13849

Dear Mr. Johnson:

An inspection of your dairy farm operation located at 331 Covered Bridge Rd., Unadilla, New York, conducted by representatives of the U.S. Food and Drug Administration (FDA) on October 12 - November 2, 2006, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

On or about August 23, 2006, you consigned a dairy cow to [redacted] who operates as [redacted] for shipment to cattle auction [redacted]. Prior to delivery to [redacted], the cow was identified with tag [redacted] and ear tag [redacted]. Wholesale cattle dealer [redacted] subsequently purchased the cow from [redacted] and delivered it to [redacted]. There it was identified with back tags [redacted] and [redacted] prior to being sold to [redacted] where it was slaughtered for human food on or about August 24, 2006. United States Department of Agriculture, Food Safety and Inspection Service (USDA/ FSIS) analysis of tissue samples collected from that animal identified the presence of 0.57 ppm penicillin in kidney tissue and 0.16 ppm penicillin in liver tissue. A tolerance of 0.05 ppm has been established for residues of penicillin in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.510 (21 CFR 556.510). The presence of this drug in these amounts in the edible tissues of this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 USC § 342(a)(2)(C)(ii)] of the Act.

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.

For example, you failed to maintain written treatment records to document the identity of the animal, treatment dates, drugs administered, dosage administered, route of administration, and withdrawal times for milk and beef. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(2) (21 U.S.C. § 342(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 ensuring that your overall operation and the food you distribute is 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 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 action cannot be completed within fifteen (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 response should be sent to Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A. Clark at 716-551-4461, extension 3168.

Sincerely yours,

/S/

Otto D. Vitillo
District Director
New York District

cc: Luke Johnson
Joleanna Holsteins
331 Covered Bridge Rd.
Unadilla, NY 13849

Josh Johnson
Joleanna Holsteins
331 Covered Bridge Rd.
Unadilla, NY 13849