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  5. My Lady's Manor Farm, Inc. - 11/24/2014
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WARNING LETTER

My Lady's Manor Farm, Inc.

Product:
Animal & Veterinary

Recipient:
My Lady's Manor Farm, Inc.


United States

Issuing Office:
Baltimore District Office

United States


   

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) 779-5455
FAX: (410) 779-5707 

WARNING LETTER
CMS# 443115

November 24th, 2014
 

Via UPS

Mr. Robert S. Smith, President/Owner
My Lady's Manor Farm, Inc.
4030 Houcks Road
Monkton, Maryland 2111 1
 

Dear Mr. Smith:

On October 14 and 16, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 4127 Old York Road, Monkton, Maryland 21111-1827. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about June 23, 2014, you sold a culled dairy cow identified with a bangle tag #(b)(4) (ear tag #(b)(4), back tag #(b)(4)) for slaughter as food. On or about June 24, 2014, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 10.0 parts per million (ppm) of neomycin residue in the kidney. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney (target tissue) of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.430, 21 C.F.R. 556.430. The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).

Our investigation also found that you hold animals under conditions that are inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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) of the FD&C Act, 21 U.S.C. 342(a)(4).

We also found that you adulterated the new animal drug Neosol Oral (neomycin sulfate antibacterial, ANADA #200-289). Specifically, our investigation revealed that you did not use Neosol Oral as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.

Our investigation found that you administered Neosol Oral (neomycin sulfate antibacterial, ANADA #200-289) to your culled dairy cow, bangle tag #(b)(4) (ear tag #(b)(4), back tag #(b)(4)), without following the recommended dose and for treating a class of animal not set forth in the approved product labeling. According to the approved labeling for Neosol Oral, it is not to be used in female dairy cattle 20 months of age or older. Your extralabel use of Neosol Oral was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Neosol Oral resulted in illegal residues, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).

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 violations described in this letter and to establish procedures to ensure that these 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 of receiving this letter, 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 David P. Rice, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101 , Baltimore, Maryland 21215. lf you have any questions about this letter, please contact Compliance Officer David P. Rice at (410) 779-5463 or e-mail at david.rice@fda.hhs.gov.
 

Sincerely yours,
/S/
Evelyn Bonnin
District Director
Baltimore District
 

Cc:
Mary O. Smith, Secretary/Treasurer
My Lady's Manor Farm, Inc.
4030 Houcks Road
Monkton, Maryland 21111

Dr. Locher Bray, DVM
Taylorsville Veterinary Clinic
4339 Ridge Road
Mount Airy, Maryland 21771

Marla Stevens, VMD
MDA Animal Health Program, Field Veterinarian, Acting Assistant State Veterinarian
50 Harry S. Truman Parkway
Annapolis, MD 21401