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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Langeland Farms 11/13/12

  

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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313-393-8100
FAX: 313-393-8139 

 

WARNING LETTER
(2013-DET-01)
 
 
November 13, 2012
 
 
VIA UPS
 
Merle J. Langeland, President
Langeland Farms
5085 Garfield Street
Coopersville, Michigan 49404-9486
 
 
Dear Mr. Langeland:
 
On September 7 and 17, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5085 Garfield Street, Coopersville, Michigan. 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. § 360(b). 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 20, 2012 you sold a dairy cow, identified with bangle tag number (b)(4) ear tag (b)(4), and back tag (b)(4) for slaughter as food. On or about February 21, 2012, (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 0.17 parts per million (ppm) of penicillin 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, Section 556.510 (21 C.F.R. 556.510). The presence of this drug in the edible tissue of this animal in this amount causes the food to be adulterated under 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 Agri-Cillin (Penicillin G Procaine) Injectable Suspension, NADA 065-010. Specifically, our investigation revealed that you did not use Agri-Cillin (Penicillin G Procaine) Injectable Suspension, NADA 065-010, as directed by its approved labeling. Use of this drug in this manner is an extralabel use, as defined at 21 C.F.R. 530.3(a).
 
The extra label use of approved animal or human drugs in animals is allowed under the Act only if the extra-label 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 Agri-Cillin (Penicillin G Procaine) Injectable Suspension, NADA 065-010, to your dairy cow without following the dose, dosage limitation per injection site, indication for use, and withdrawal period, as stated in the approved labeling. Your extralabel use of Agri-Cillin (Penicillin G Procaine) Injectable Suspension, 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 Agri-Cillin (Penicillin G Procaine) Injectable Suspension, NADA 065-010, resulted in an illegal drug 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 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 Tina M. Pawlowski, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact Compliance Officer Pawlowski at (313) 393-8217 or by email at tina.pawlowski@fda.hhs.gov.
 
 
Sincerely yours,
/S/ 
Glenn T. Bass
District Director
Detroit District Office
 
cc:     
Marlin Langeland, Co-Owner
Langeland Farms
5085 Garfield Street
Coopersville, Michigan 49404-9486
 
Melanie A Brownlee
Cervid and Reportable Disease Program Secretary
Michigan Department of Agriculture and Rural Development
Animal Industry Division