Rohrer Dairy Farms Llc 9/24/10

Department 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
10-PHI-13

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

September 24, 2010

Robert L. Rohrer, Co-owner and Partner
Rohrer Dairy Farms, LLC
126 Charlestown Road
Washington Boro, Pennsylvania 17582-9669

Dear Mr. Rohrer:

On June 9, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 126 Charlestown Road, Washington Boro, Pennsylvania. 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 February 9, 2010, you sold a dairy cow identified with back tag (b)(4) ear tag (b)(4) and farm tag (b)(4) for slaughter as food. On or about February 10, 2010, (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 penicillin at (b)(4) parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.510 (21 C.F.R. 556.510). 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 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 complete 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).

We also found that you adulterated the new animal drug Penicillin G Procaine Injectable Suspension U.S.P., NADA 065-010. Specifically, our investigation revealed that you did not use Penicillin G Procaine Injectable Suspension U.S.P., NADA 065-010, 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 Act only if the extralabel use complies with sections 512(a)(4) and (5) of the 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 Penicillin G Procaine Injectable Suspension U.S.P., NADA 065-010, in your dairy cow identified with back tag (b)(4) ear tag and farm tag (b)(4) in a manner not set forth in the approved labeling. Your extralabel use of Penicillin G Procaine Injectable Suspension U.S.P., NADA 065-010, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Penicillin G Procaine Injectable Suspension U.S.P., NADA 065-010, resulted in an illegal residue, 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 Act, 21 U.S.C. 360b(a), and 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 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 are reminded that an FDA Warning Letter dated April 1, 1997, was issued to you for a violative sulfadimethoxine tissue residue in a dairy cow that originated from your farm and was offered for slaughter for food in April 1996. We are attaching a copy of the April 1, 1997 FDA Warning Letter for your information and review.

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 Ms. Robin Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Compliance Officer Robin Rivers at (215) 717-3076 or e-mail.at Robin.Rivers@fda.hhs.gov.

Sincerely yours,

/s/

Kirk D. Sooter
District Director
Philadelphia District

 

 

Enclosures:

FDA-483 dated June 9, 2010
FDA Warning Letter dated April 1, 1997

 

cc: Michael Rohrer, Co-owner and Partner
Rohrer Dairy Farms LLC
126 Charlestown Road
Washington Boro, Pennsylvania 17582-9669

Anthony Rohrer, Co-owner and Partner
Rohrer Dairy Farms LLC
126 Charlestown Road
Washington Bora, Pennsylvania 17582-9669

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

USDA/FSIS
Office of Policy, Program & Employee Development
Policy Development Division
1616 Capital Avenue, Suite 260
Omaha, Nebraska 68102

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