Lapp, John 4/14/10

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

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 

WARNING LETTER
10-PHI-06

April 14, 2010

Mr. John K. Lapp, Owner
15866 State Route 44
Allenwood, Pennsylvania 17810-9337

Dear Mr. Lapp:

On February 22, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 15866 State Route 44, Allenwood, Pennsylvania 17810-9337. 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 June 8, 2009, you sold a bob veal calf identified with ear tag (b)(4) for slaughter as food. On or about June 9, 2009, (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 0.1013 parts per million (ppm) of flunixin in the liver tissue. FDA has not established a tolerance for residues of flunixin in the edible tissues of veal calves. The presence of this drug in edible tissue from this animal 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 flunixin meglumine (Flu-Nix D). Specifically, our investigation revealed that you did not use Flu-Nix D as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 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 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 flunixin meglumine in a class of animal (veal calf) not set forth in the approved labeling and you did so without following the extralabel use directions of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a). Furthermore, your extralabel use of Flunixin Meglumine resulted in an illegal residue, in violation of 21 C.F.R. 530.11 (c). 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 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 James C. Illuminati, 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 James C. Illuminati at (215) 717-3078 or Email at jillumin@ora.fda.gov.

Sincerely yours,

/s/

 

Kirk D. Sooter
District Director
Philadelphia District

jci

Enclosure: Form FDA 483 dated February 22, 2010

cc: 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
1299 Farnam Street, Suite 300
Omaha, Nebraska 68102

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