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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Sinan Dairy Farm 7/24/13

  

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
 13-PHI-27
 
 
July 24, 2013
 
Delivered via United Parcel Service
                                                                                                     
Ms. Sandra V. Sinan, Co-owner
Mr. Milos M. Sinan, Co-owner
Sinan Dairy Farm
570 Minich Road
Home, Pennsylvania 15747
 
Dear Ms. and Mr. Sinan:
 
On May 22, 24, and 29, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 570 Minich Road, Home, Pennsylvania. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that were 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 animals for slaughter as food that were 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 April 3, 2013, you sold a dairy cow, identified with back tag (b)(4) and bangle tags (b)(4) and (b)(4), for slaughter as food. On or about April 4, 2013, (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 tilmicosin at (b)(4) parts per million (ppm) in the liver and detected the presence of sulfadoxene in the kidney. FDA has established a tolerance of 1.2 ppm for residues of tilmicosin in the liver of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.735(b)(1) (21 C.F.R. 556.735(b)(1)). FDA has not established a tolerance for residues of sulfadoxene in the edible tissues of cattle. As such, there is no acceptable level of residue associated with the use of this drug in cattle.  The presence of these drugs 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). 
 
In addition, our investigation revealed that on or about January 2, 2013, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about January 3, 2013, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of gentamicin in the kidney. FDA has not established a tolerance for residues of gentamicin in the edible tissues of cattle, including calves to be processed for veal. 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 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 new animal drug Micotil 300 (tilmicosin) Injection, NADA 140-929. Specifically, our investigation revealed that you did not use Micotil 300 (tilmicosin) Injection, NADA 140-929, as directed by your servicing veterinarian’s written prescription. Use of this drug in this manner is an extralabel use. For the definition of 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 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 Micotil 300 (tilmicosin) Injection, NADA 140-929, to your dairy cow, identified with back tag (b)(4) and bangle tags (b)(4) and (b)(4), without following the withdrawal period as stated in your servicing veterinarian’s written prescription. Your extralabel use Micotil 300 (tilmicosin) Injection, NADA 140-929, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use Micotil 300 (tilmicosin) Injection, NADA 140-929, 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 your servicing veterinarian’s written prescription and did not comply with 21 C.F.R. Part 530, you caused the drug 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 timeframe 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 Richard Cherry, 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 Mr. Cherry at 215-717-3075 or richard.cherry@fda.hhs.gov.
 
Sincerely yours,
/S/
Anne E. Johnson
Acting District Director
Philadelphia District
 
cc:      
 
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 North Cameron Street
Harrisburg, Pennsylvania 17120
 
Dr. Thomas Alexander
Chief of Regulation and Compliance
Pennsylvania Department of Agriculture
Bureau of Animal Health
Room 408
2301 North Cameron Street          
Harrisburg, Pennsylvania 17110
 
Alquin F. Heinnickel, III, D.V.M.
Five Points Veterinary Services
3528 Route 981
Saltsburg, Pennsylvania 15681