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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Wisteria Gardens Dairy 20-Oct-03

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

Public Health Service
Food and Drug Administration

 

Florida District
655 Winderley Place
Suite 200
Maitiand, Florida 32751
Teie #:(407)475-4700
Fax: (407) 475-4769



CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-04-04

October 20, 2003


Sam R. Wright, Owner .
Wisteria Gardens Dairy
2899 Wisteria Farm Road
Green Cove Springs, Florida 32043

Dear Mr. Wright:

Investigators from the U.S. Food and-Drug Administration (FDA) conducted an investigation of your dairy farm on July 23 and 24, 2003. FDA Investigator Harry R. Bringger, Jr. confirmed that you offered animals 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) [21 U.S.C. §§ 342(a)(2)(C)(ii) and (a)(4)].

In addition, you have caused an animal drug to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)].

Our investigation revealed that on or about April 15-18, 2003, you sold two cull dairy cows, one identified by your ear tag number [redacted], and subsequently identified by back tag number [redacted] and USDA sample number [redacted] and one identified by your ear tag number [redacted] and subsequently identified by back tag number [redacted] and USDA sample number [redacted] for slaughter as human food to [redacted]. USDA analysis of tissue samples collected from these animals identified the presence of gentamicin in the kidneys of the animals at a level of 1.60 and 0.12 parts-per million (ppm), respectively. Analysis of USDA sample number 440381 also identified gentamicin in the liver of the animal at a level of 0.05 ppm. There is no tolerance established for residues of gentamicin in the edible tissues of dairy cattle. The presence of this drug in the edible tissues of these animals causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act [21 U.S.C. §342(a)(2)(C)(ii)].

Our investigation also found that you hold animals under conditions that are inadequate to ensure that medicated animals bearing potentially harmful drug residues are prevented from entering the food supply. Specifically, you failed to withhold these animals from sale for slaughter for the six month withdrawal period stated on the prescription labeling; you failed to systematically review treatment records prior to offering an animal for sale for slaughter for human food to ensure that appropriate withdrawal times have been observed; and, your dairy lacks a drug inventory/accountability system to ensure that there is no unaccounted drug use or missing drugs at the dairy. Food from animals held under these conditions is adulterated within the meaning of section 402(a)(4) of the Act. [21 U.S.C. § 342(a)(4)]

You are also adulterating prescription drugs used in your operation. A drug is adulterated within the meaning of section 501(a) (5) of the Act [21 U.S.C. § 351(a)(5)] if it is administered in a manner other than in accordance with its labeled directions or in accordance with the extra-label-use provision in Title 21, Code of Federal Regulations, Part 530 (21 CFR Part 530). In failing to properly follow labeled directions, you made the drug unsafe within the meaning of section 512(a)(1)(B) of the Act [21 U.S.C. § 360b(a)(1)(B)]. 0ur investigation found that your dairy manager had treated cows with gentamicin sulfate injection between March 16-17, 2003 and April 4-5, 2003 prior to the animals being sold to a livestock dealer. As a result of your failure to adhere to the prescribed withdrawal time, as required by 21 CFR Part 530, the drug is unsafe under section 512(a)(1)(B) of the Act. [21 U.S.C. § 360b(a)(1)(B)] and adulterated under section 501(a)(5) [21 U.S.C. § 351(a)(5)].

This letter 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 'ood you distribute are in compliance with the law.

You should take prompt action to correct these violations and to establish procedures to prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure 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 two animals that were sold to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.

Within fifteen (15) working days of receipt of this letter, you should notify this office in writing of the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct-the violations and prevent the recurrence of similar violations. If corrections 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. Also, include copies of any available documentation demonstrating that corrections have been made.

Your reply should be directed to Martin E. Katz, Compliance Officer; U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, telephone (407)475-4729.

Sincerely,

/s/

Emma.R. Singleton
Director, Florida District

cc: Lee Bruey, DVM
595 S. Lawrence
Keystone Heights, Florida 32650