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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Old Carolina Farms 16-Jan-08

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


FEI: 3000203759

January 16 , 2008

WARNING LETTER

08-BLT-03

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Francis H. Roderick
Old Carolina Farms
10802 Cook Brothers Road
Ijamsville, Maryland 21754

Dear Mr. Roderick:

An inspection of your dairy operation located at 10802 Cook Brothers Road, Ijamsville, Maryland, conducted by a representative of the U.S. Food and Drug Administration (FDA) between October 16, 2007, and November 27, 2007, confirmed that you offered a bob veal calf for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act) . The inspection also revealed that you caused the new animal drug, [redacted] (sulfamethazine) [redacted] to become unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. In addition, the inspection revealed that you provided a false guaranty, a prohibited act under section 301(h) of the Act [21 U.S.C. § 331(h)], You can find the Act and its associated regulations on the Internet through links on the FDA's web page at
www.fda.gov.

On or about July 25, 2007, you consigned a bob veal calf, identified with tag [redacted], for slaughter as food an [redacted]. On or about July 26, 2007, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 131.89 parts per million (ppm) of sulfamethazine in the liver tissue and 179.88 ppm of sulfarnethazine in the muscle tissue of this animal. A tolerance of 0.1 ppm has been established for residues of sulfamethazine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.670 [21 C.F.R. 556.670]. The presence of this drug in these amounts in edible) tissues from this animal causes 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.

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lackS an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Act.

Furthermore, on or about April 9, 2001, you provided [redacted] with a signed certification, which states that you will not supply [redacted] with any livestock that is "adulterated within the meaning of the Federal Food (Drug] and Cosmetic Act (i.e., none of the cattle or other ruminants will have been fed any feed containing protein derived from mammalian tissues, e.g. meat and bone meal, as that term is defined in 21 C.F.R. 589.2000 and none of the livestock will have an illegal level of drug residues)." On July 25, 2007, you delivered to [redacted] a bob veal calf containing illegal levels of sulfamethazine residues. Providing such a false guaranty is a prohibited act under section 301(h) [21 U.S.C. § 331(h)) of the Act.

In addition, you adulterated [redacted] (sulfamethazine) [redacted] within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of [redacted] (sulfamethazine) [redacted] failed to comply with these requirements. For example, you administered these [redacted] (sulfamethazine) [redacted] without following the withdrawal period set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of this drug was not in compliance with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) [21 U.S.C. § 360b(a)} of the Act and your use caused it to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] 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 frame 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 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 Mr. Barber at 410-779-5134.

Sincerely yours,

/S/

Kirk Sooter
Acting District Director

cc: Dr. David F. Vogt
USDA, APHIS, VS
1598 Whitehall Road, Suite A
Annapolis, Maryland 21401

FSIS District Office
5601 Sunnyside Avenue Suite 1-2288 B
Beltsville, Maryland 20705

[redacted]

[redacted]