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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Sullivan, J Ralph 12-Feb-04

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

Public Health Service
Food and Drug Administration

 

Dallas District
4040 North Central Express
Dallas, Texas 75204-3145


February 12, 2004

Ref: 2004-DAL-WL-11

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. J. Ralph Sullivan, Owner
HC 62, Box 2014
Pittsburg, Oklahoma 74560

Dear Mr. Sullivan:

A report received by the U.S. Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of illegal drug residues in a cow that originated from your cattle operation. An investigation performed by the U.S. Food and Drug Administration (FDA) included visits to your cattle operation located at Pittsburg, Oklahoma, November 4 through 6, 2003. The investigation 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).

A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it contains a new animal drug that is unsafe within the meaning of Section 512 of the Act. On July 8, 2003 you sold a cow, identified with a back tag number [redacted], ear tag number [redacted] at [redacted]. The cow was purchased by a dealer and offered for slaughter as human food on July 14, 2003 at [redacted] USDA Establishment Number [redacted] USDA analysis (Laboratory Report #[redacted])of tissue samples collected from that animal identified the presence of gentamicin, a drug not approved for use in cattle, in the kidney. Because the drug may not be lawfully used in cattle, no tolerance has been established for gentamicin sulfate in uncooked edible tissues of cattle. (Title 21, Code of Federal Regulations, Section 556.300). The presence of this drug in edible tissue from this animal causes the food to be adulterated.

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 to this case "insanitary conditions" means that you hold animals which are offered for sale for slaughter as food under conditions which may allow medicated animals bearing potentially harmful drug residues to enter the food supply.

For example, our investigators noted the following conditions on your farm.

1. You lack an adequate system for assuring that drugs are used in a manner not contrary to the directions contained in their label or labeling.

2. Your firm does not have a system for assuring that animals have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.

Foods from animals held under such conditions are adulterated. 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.

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

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 that has been taken or will be taken to correct the violations and prevent their recurrence. If the 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 reply should be directed to the Food and Drug Administration, Attention: Reynaldo R. Rodriguez, Jr., Director, Compliance Branch.

Sincerely,

/S/

Michael A. Chappell
Dallas District Director

MAC: rrr