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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sullivan Lane Farm 3/26/12

  

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

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
12-PHI-12

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 

March 26, 2012 


Mr. Benny N. Fisher, Owner
Sullivan Lane Farm
765 Springs Road
Springs, PA 15562-2401


Dear Mr. Fisher:


On January 5, 2012 and January 12, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 765 Springs Road, Springs, PA. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the 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 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 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 Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the 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 October 24, 2011, you sold a dairy cow, identified with tag (b)(4) for slaughter as food. On or about October 25, 2011, (b)(4) slaughtered this animal. (b)(4) customers through interstate trade. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.288 parts per million (ppm) Sulfamethazine residue in the liver. FDA has not established a tolerance for residues of Sulfamethazine in dairy cows. The presence of this drug in edible tissues from this animal, cause 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. 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 Act, 21 U.S.C. § 342(a)(4).


The above is not intended to be an all-inclusive list of violations. As a grower 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.


Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of there-inspection and assessing and collecting there-inspection fees (21 U.S.C. 379j-31 (a)(2)(B)).


FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility.


The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.


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 Robin M. Rivers, Compliance Officer, United States Food and Drug Administration, United States Customs House, Room 900, 2nd & Chestnut Street, Philadelphia, PA 19106. If you have any questions about this letter, please contact Ms. Rivers at 215-717-3076.


Sincerely,
/S/
Kirk D. Sooter
District Director
Philadelphia District Office