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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Wright Whitty Davis Farms Inc 09-Oct-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

Public Health Service
Food and Drug Administration

 

Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
Telephone: 404-253-1161
FAX: 404-253-1202


October 9, 2001

VIA FEDERAL EXPRESS

William P. Wright
President
Wright Whitty Davis Farms, Inc.
18 Holstein Lane
Baxley, Georgia 31513

WARNING LETTER
(1-ATL-02)

Dear Mr. Wright:

An inspection of your dairy operation located in Baxley, Georgia, conducted by Investigator B. Douglas Brogden on August 22 & 30 and September 5, 2001, confirms that four cows sold by you on/or about 5/22/01, 5/30/0l, 6/19/01 and 6/20/01, for slaughter for human food to [redacted] was in violation of Section 402(a)(2)(C)(ii) and 402 (a)(4) of the Federal Food, Drug, and Cosmetic Act, and that you may have caused animal drugs to become adulterated within the meaning of Section 501(a)(5).

USDA/FSIS analysis of tissues collected from the four animals disclosed the presence of penicillin in the kidney, liver and muscle. On cow bearing back tag [redacted] USDA reported finding 0.12 parts per million (ppm) penicillin in muscle and 01.17 ppm penicillin in kidney. On a second cow bearing back tag [redacted] USDA reported finding 0.08 ppm penicillin in kidney and 0.11 ppm penicillin in liver. On a third cow bearing back tag [redacted] USDA reported 0.50 ppm penicillin in kidney. The fourth cow bearing back tag [redacted] USDA reported finding 0.48 ppm penicillin in liver, 0.16 ppm penicillin in muscle and 01.20 ppm penicillin in kidney. A tolerance of 0.05 ppm has been established in residues for penicillin in the uncooked edible tissue of cattle (Title 21 Code of Federal Regulations Section 556.510). The presence of this drug in edible tissue from these animals causes the food to be
adulterated.

Our investigation also found that one of your facilities, [redacted], did not maintain medication records of cattle medicated during May and June, 2001. Also, medication records maintained by dairy #2 and dairy #3 do not always indicate the dose level of the drug administered and method, of administration.

You are adulterating the drug Penicillin G Procaine Injectable Suspension that your firm uses on cows within the meaning of Section 501(ax5) when you fail to use the drug in conformance with its approved labeling. The labeled four day withdrawal period and 10 mL dosage recommendation have not always been followed. Cows have been, given daily dosages of 40 cc's to a maximum dose of 60 cc's and have been sold for slaughter after a two day withdrawal.

The violations listed above are not intended to be an all inclusive list. It is your responsibility to assure that your operations are in compliance with the law. To avoid future illegal residue violations, you should take precautions such as implementing a system to withhold the animal, if it has been medicated, from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.

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 be aware that it is not necessary for you to have personally shipped an animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an animal 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 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: Sheryl R. Cruse,
Compliance Officer, at the above noted address.

Sincerely yours,

/S/

Ballard H. Graham, Director
Atlanta District