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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Shank Farms, Inc. 1/17/14

  

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 

January 17, 2014
 

WARNING LETTER
CMS# 418722

Via UPS

Mr. Garry B. Shank, President
Shank Farms, Inc.
19608 Granada Court
Hagerstown, MD 21742

Dear Mr. Shank:

An investigation of your dairy operation located at 19619 Leitersburg Pike, Hagerstown, MD 21742, conducted by a representative of the U.S. Food and Drug Administration (FDA) on November 18 and December 11, 2013, confirmed that you offered an animal for sale 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. Furthermore, 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 in sanitary conditions whereby it may have been rendered injurious to health. 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 4, 2013, you sold a cow, identified by tag "(b)(4)" applied by (b)(4), for slaughter as food. On or about July 5, 2013 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 desfuroylceftiofur in the kidney at a level of 1.23 parts per million. Desfuroylceftiofur is a marker residue of the drug Ceftiofur. FDA has established a tolerance of 0.4 ppm for the marker residue Desfuroylceftiofur in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.113 (21 C.F.R. § 556.113). The presence of Desfuroylceftiofur 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 Act, 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 and you lack an adequate inventory system for determining the quantities of drugs used to medicate your animal(s). 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)].

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.

Please send your written reply to the U.S. Food and Drug Administration, Attention: Ernest F. Bizjak, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Bizjak by phone at 410-779-5715 or by email at ernest.bizjak@.fda.hhs.gov.
 

Sincerely yours,
/S/

Evelyn Bonnin
District Director
Baltimore District Office
 

CC :
Dr. Isabel Arrington, Director TA/C
United States Department of Agriculture (USDA)
Food Safety and Inspect ion Service (FSIS)
Office of Policy and Program Development
1616 Capitol Avenue, Suite 260
Omaha, NE 68102
 

 
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