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U.S. Department of Health and Human Services

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Enforcement Actions

Lin-Ro Farms 9/12/12

  

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 end Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390

WARNING LETTER
12-PHI-28


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 

September 12, 2012


Matthew Sensenig, Owner and Producer
Lin-Ro Farms
285 Scott Road
Quarryville, Pennsylvania 17566

Dear Mr. Sensenig:

On July 20, 23, and 26, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 276 Scott Road, Quarryville, Pennsylvania.  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 May 8, 2012, you sold a bob veal calf, identified with tag (b)(4) , for slaughter as food.  On or about May 9, 2012, (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 sulfamethoxazole at 1.857 parts per million (ppm) in the muscle and at 1.477 ppm in the liver.  FDA has not established a tolerance for residues of sulfamethoxazole in the edible tissues of cattle.  The presence of this drug in edible tissues from this animal in these amounts 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 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 FD&C Act, 21 U.S.C. § 342(a)(4).

We also found that you adulterated the human drugs sulfamethoxazole and trimethoprim.  Specifically, our investigation revealed that you did not use the sulfamethoxazole and trimethoprim product as directed by its approved labeling.  Use of these drugs in this manner is an extralabel use, Title 21, Code of Federal Regulations, Part 530.3(a) (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 the human drugs sulfamethoxazole and trimethoprim to a bob veal calf without following the indications for use as stated in the approved labeling.  Your extralabel use of the human drugs sulfamethoxazole and trimethoprim was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c).  Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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 Yvette Johnson, Compliance Officer, U.S. Food and Drug Administration, U.S. Customhouse, Room 900, 200 Chestnut Street, Philadelphia, Pennsylvania 19106.  If you have any questions about this letter, please contact Ms. Johnson at (215) 717-3077 or e-mail at Yvette.Johnson@fda.hhs.gov.

Sincerely,

/S/

Kirk D. Sooter
District Director
Philadelphia District


Enclosure(s):

     FDA-483 dated July 26, 2012


cc: Robert L. Sensenig, Owner
     Lin-Ro Farms
     285 Scott Road
     Quarryville, Pennsylvania 17566

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

     Dr. David R. Griswold, Acting Director
     Pennsylvania Department of Agriculture
     Bureau of Animal Health and Diagnostic Services (BAHDS)
     2301 Cameron Street
     Harrisburg, Pennsylvania 17120

    Anthony LaBarbera
    Chief of Regulation and Compliance
    Pennsylvania Department of Agriculture 
    Bureau of Animal Health
    Room 408
    2301 North Cameron Street
    Harrisburg, Pennsylvania 17110