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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Elam Fisher 10/31/13

  

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) 779-5705 

FEI: 3010007624
 

WARNING LETTER
CMS# 410901

October 31, 2013
 

Certified Mail
Return Receipt Requested

Mr. Elam Fisher, Owner
201 Marshall Lane
Rising Sun, MD 21911
 

Dear Mr. Fisher:

An investigation of your dairy operation located at 201 Marshall Lane, Rising Sun, MD 21911, was conducted by a representative of the U.S. Food and Drug Administration (FDA) between July 30, 2013 and August 20, 2013. This letter notifies you ofthe violations ofthe Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the internet through links on the FDA's web page at www.fda.gov.

We found that you offered an animal 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)], 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) [21 U.S.C. 342 (a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act) a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been injurious to health.

Specifically, our investigation revealed that on or about November 21, 2012, you sold a dairy cow for slaughter as food to (b)(4). On November 21,2012, this animal was slaughtered at (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.75ppm of Desfuroceftiofur. A tolerance level of 0.4ppm has been established for residues of Desfuroceftiofur in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations Part 556.113 (21 C.F.R. 556.113). Desfuroylceftiofur is a marker residue of the drug Ceftiofur. The presence of this drug 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)].

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 lack 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, you failed to identify and maintain records regarding the identity of the animals that you purchase and deliver for sale at a slaughter house, and you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. 342 (a)(4)].

In addition, you adulterated Excenel RTU (ceftiofur hydrochloride sterile suspension) 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) and 512 (a)(5) of the Act and 21 C.P.R. part 530. Our investigation found that your extralabel use of Excenel RTU (ceftiofur hydrochloride sterile suspension) failed to comply with these requirements.

For example, you administered the Excenel RTU (ceftiofur hydrochloride sterile suspension) without following the dosage level set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.P.R. 530.11 (a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.P.R. 530.11(c). Because your extralabel use ofthis drug was not in compliance with 21 CFR part 530, the drug was unsafe under section 512 (a) of the Act [21 U.S.C. 360b (a)] and your use caused it to be adulterated within the meaning of section 501 (a)(5) of the 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 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. You 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 Attention: Ernest F. Bizjak, Compliance Officer at U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101 Baltimore, MD 21215. If you have any questions about this letter, please contact the Mr. Bizjak by phone 410-779-5715 or by email at Emest.bizjak@fda.hhs.gov.
 

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

Cc:
Dr. Isabel Arrington, Director TNC
United States Department of Agriculture (USDA)
Food Safety and Inspection Service (FSIS)
Office of Policy and Program Development
1616 Capitol A venue, Suite 260
Omaha, NE 681 02
 

Laurie Bucher, Chief
Maryland Department of Health and Mental Hygiene
Office ofFood Protection
Center for Milk & Dairy Product Safety
1360 Marshall Street
Hagerstown, MD 21740
 

Guy Hohenhaus, DVM
State Veterinarian
Maryland Department of Agriculture
Animal Health Program
50 Harry S. Truman Parkway
Annapolis, MD 21401