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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Albert J. Bender Farm 12-Aug-02

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

Public Health Service
Food and Drug Administration

 

Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410)779-5454
FAX: (410)779-5707



02-BLT-19

August 12, 2002

WARNING LETTER

CERTIFIED MAIL-RETURN RECEIPT REOUESTED

Mr. Albert J. Bender
Albert J. Bender Farm
10158 Boteler Road
Calverton, Virginia 20138

Dear Mr. Bender:

An investigation of your dairy farm located at 10158 Boteler Road, Calverton, Virginia, by a Food and
Drug Administration (FDA) investigator on June 10, 2002, confirmed that you offered a cow for sale for slaughter as food, in violation of Section 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

On or about September 26, 2001, you sold a dairy cow identified with back tag number 2024, to [redacted]. a livestock dealer, who subsequently sold the cow to [redacted]. The cow was then slaughtered for use as human food. U.S. Department of Agriculture (USDA) analysis of tissue samples collected from the cow confirmed the presence 0.09 ppm penicillin in the kidney tissues of the cow. A tolerance of 0.45 pprn penicillin has been established for residues of penicillin in the uncooked edible tissues of cattle (Title 21, Code of Federal Regulations (CFR), Part 556.510). The presence of this drug in excess of established tolerance levels in the edible tissues of cattle causes the food to be adulterated.

Our investigation also found that you hold animals under conditions which may allow diseased animals
and/or medicated animals bearing potentially harmful drug residues to enter the food supply. For
example:

> You routinely provide an additional 5cc's of penicillin per dose and one more treatment per day per cow than prescribed in the labeling, and do not adhere to the withdrawal times prescribed in
the labeling.
> You do not follow the directions for use listed on the labels of the medications you use and/or the required withdrawal times. Specifically, you treated a cow(back tag #[redacted]) with a milk replacer containing Neomycin, up to the day it was taken to the livestock market. The label requires a 30 day withdrawal period after using this product.
>You do hot maintain medication/treatment records that identify the animal, the date of treatment, the drug used, dosage administered, and the drug withdrawal time(s).
>You do not have a system in effect for the review of treatment records to assure that drugs have been used as directed in the labeling and that the appropriate withdrawal times have been observed.

An FDA 483, Inspectional Observations, was issued to you at the conclusion of the inspection.

In addition, USDA has reported, and the inspection confirmed findings; of illegal residues in four other cattle sold by you and offered for slaughter for human food. The findings of illegal residues are as follows:

DATE

TAG#

DRUG

TISSUE TYPE & RESIDUE LEVEL

TOLERANCE

3/5/99

[REDACTED]

Penicillin

Liver - 0.14 ppm

Kidney - 0.50 ppm

0.05 ppm

0.05 ppm

12/10/99

[REDACTED]

Penicillin

Kidney - 0.08 ppm

0.05 ppm

1/19/01

[REDACTED]

Neomycin

Liver - 09.26 ppm

Kidney - 253.16 ppm

3.6 ppm

7.2 ppm

9/26/01

[REDACTED]

Penicillin

Kidney - 0.09 ppm

0.05 ppm

The above is not intended to be an all-inclusive list of the violations that may be occurring at your farm. As a producer of animals offered for use as food, you are responsible for assuring that your overall operations and the food 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 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 FD&C 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 FD&C 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 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 documentation demonstrating that corrections have been made.

Your response should be directed to Ms. Rosalie Bucey, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, telephone number (410) 779-
5417.

Sincerely,

/s/

Lee Bower
Director, Baltimore District