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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Lucky Acres 7/27/09

  

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
09-PHI-07


July 27, 2009


Amos S. King, Owner
Lucky Acres
3167 Kissel Hill Road
Lititz, Pennsylvania 17543-9232


Dear Mr. King:


On December 12 and 18, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 3167 Kissel Hill Road, Lititz, 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. 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 July 7, 2008, you sold a dairy cow, identified with back tag (b)(4), and ear tag (b)(4) for slaughter as food. On or about July 8, 2008, (b)(4) located in (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 sulfadimethoxine in the liver at 0.95 parts per million (ppm) and in the muscle at 1.03 ppm and penicillin in the liver at 0.13 ppm FDA has established a tolerance for residues of sulfadimethoxine in the uncooked edible tissues of cattle at 0.1 ppm as codified in Title 21, Code of Federal Regulations, Section 556.640 (21 C.F.R. 556.640,and a tolerance for residues of penicillin in the uncooked edible tissues of cattle at 0.05 ppm as codified in 21 C.F.R. 556.510 The presence of these drugs in edible tissue from this animal  in these amounts 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. 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 drugs sulfadimethoxine and penicillin. Specifically, our investigation revealed that you did not use sulfadimethoxine and penicillin as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. 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 sulfadimethoxine to a dairy cow identified with back tag (b)(4) and eartag (b)(4), without following the indications for use contained in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cows by 21 C.F.R. 530.41(a)(9). Further, your extralabel use of this drug resulted in illegal drug residues in this animal, in violation of 21 C.F.R. 530.11(d). In addition, our investigation found that you administered penicillin to a dairy cow, identified with back tag (b)(4) and ear tag (b)(4) without following the indications for use or dose contained in the approved labeling. Your extralabel use of penicillin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel uses 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 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 foods you distribute are in compliance with the law. 


You should take prompt action to correct the above violations 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, 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 via e-mail at jillumin@ora.fda.gov.


Sincerely,

/S/
Kirk Sooter
Director
Philadelphia District