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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Eury, Edward J., Jr. 27-Jul-07

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

Public Health Service
Food and Drug Administration

 

Baltimore District Office
6000 Metro Drive
Suite 101
Baltimore, MD 21215-3215
Telephone: (410) 779-5454


July 27, 2007

WARNING LETTER
200266

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Edward J. Eury, Jr.
1712 Rohresville Rd.
Knoxville, Maryland 21758

Dear Mr. Eury:

An investigation of your veal calf operation, conducted by a representative of the U.S. Food and Drug Administration (FDA) on March 13, March 20, April 20, April 24, and April 27, 2007, confirmed that you offered animals for sale for slaughter as food that were adulterated under section 402(a)(2)(C)(ii) [21 U.S.C. 342 (a)(2)(C)(ii)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links in FDA's web page at www.fda.gov.

On or about January 31, 2007, you sold a veal calf (tag 395) to [redacted]. On that same day, [redacted] bought this animal for slaughter as food. On February 1, 2007, this animal was slaughtered at [redacted]. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 4.39 parts per million (ppm) of sulfamethazine in muscle tissue and 5.98 ppm sulfamethazine in liver tissue.

On or about March 1, 2007, you sold a second veal calf (tag 1474) to [redacted]. On that same day, [redacted] bought this animal for slaughter as food. On March 2, 2007, this animal was slaughtered at [redacted]. USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 15.80 ppm of sulfamethazine in muscle tissue and 22.01 ppm sulfamethazine in liver tissue. In addition, USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 69.27 ppm neomycin in kidney tissue. The presence of these drugs in these amounts in edible tissue from these animals cause the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] 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 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 Mr. Steven B. Barber, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about this letter, please contact Compliance Officer Steven B. Barber at 410-779-5134.

Sincerely,

/s/

Evelyn Bonnin
District Director
Baltimore District

cc: (redacted)
Isabel Arrington, D .V .M.
USDA-FSIS, Technical Service Center
Landmark Center, Suite 300
1299 Farnam Street
Omaha, Nebraska 68102

Dr. Thomas Jacobs, Assistant State Veterinarian
Office of Marketing, Animal Industries and Consumer Services
Maryland Department of Agriculture
50 Harry S. Truman Parkway
Annapolis, Maryland 21401

Dr. Anthony P. LaBarbera, Chief
Regulations and Compliance Division
Bureau of Animal Health & Diagnostic Services
Pennsylvania Department of Agriculture
2301 North Cameron Street
Harrisburg, Pennsylvania 17110