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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ivy Farms, Inc. 3/4/13

  

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

Public Health Service
Food and Drug Administration
 New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781-587-7500
Fax 781-587-7556 

 

WARNING LETTER
CMS # 393196
 
VIA UPS Next Day Air
 
DATE: March 4, 2013
 
Jon J. Yandow, Owner
Ivy Farms, Inc.
3584 Lower Newton Road
Swanton, Vermont 05488-8533
 
Dear Mr. Yandow:
 
On January 9, 11, and 28, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 3584 Lower Newton Road, St. Albans, Vermont.  This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we 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 an animal for slaughter as food that was 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 February 16, 2012, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about February 17, 2012, (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 sulfamethoxazole at 0.102 parts per million (ppm) in the liver tissue. FDA has not established a tolerance for residues of sulfamethoxazole in calves to be processed for veal. The presence of this drug in the edible tissue from this animal in this 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).
 
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 drugs:
 
  • Sulfamethoxazole and Trimethoprim Double Strength Tablets, USP, (b)(4);
  • Dexamethasone, (b)(4);
  • (b)(4) (florfenicol and flunixin meglumine), (b)(4);
  • (b)(4) (penicillin G procaine) Injectable Suspension, (b)(4); and,
  • (b)(4) (oxytetracycline hydrochloride) Injection, (b)(4).
Specifically, our investigation revealed that you did not use:
  • Sulfamethoxazole and Trimethoprim Double Strength Tablets, USP, (b)(4);
  • Dexamethasone, (b)(4);
  • (b)(4) (florfenicol and flunixin meglumine), (b)(4);
  • (b)(4) (penicillin G procaine) Injectable Suspension, (b)(4); and,
  • (b)(4) (oxytetracycline hydrochloride) Injection, (b)(4), as directed by their approved labeling or by your servicing veterinarians’ prescriptions.  Use of these drugs in this manner is an extralabel use as defined under Title 21, Code of Federal Regulations (C.F.R.), Section 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 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 Sulfamethoxazole and Trimethoprim Double Strength Tablets, USP, (b)(4), to a bob veal calf, identified with back tag (b)(4), without following the withdrawal period as prescribed by one of your servicing veterinarians.  Your extralabel use of Sulfamethoxazole and Trimethoprim Double Strength Tablets, USP, (b)(4), was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use Sulfamethoxazole and Trimethoprim Double Strength Tablets, USP, (b)(4), resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c).
 
Our investigation also found that you administered Dexamethasone, (b)(4), sometimes in combination with (b)(4) (a nonsterile food product), and sometimes as the sole drug product, to your lactating dairy cows without following the indications for use as prescribed by one of your servicing veterinarians.  Your extralabel use of Dexamethasone, (b)(4), was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).
 
Our investigation also found that you administered (b)(4) (florfenicol and flunixin meglumine), (b)(4), to your calves without following the established injection site location as stated in the approved labeling.  Your extralabel use of (b)(4) (florfenicol and flunixin meglumine), (b)(4), was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).
 
Our investigation also found that you administered (b)(4) (penicillin G procaine) Injectable Suspension, (b)(4), to your animals without following the indications for use as stated in the approved labeling.  Your extralabel use of (b)(4)(penicillin G procaine) Injectable Suspension, (b)(4), was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).
 
Our investigation also found that you administered (b)(4) (oxytetracycline hydrochloride) Injection, (b)(4), to your animals without following the indications for use and route of administration as stated in the approved labeling.  Your extralabel use of (b)(4)(oxytetracycline hydrochloride) Injection, (b)(4), was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).
 
Because your extralabel use 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 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 the Director Compliance Branch, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, Massachusetts 02180.  If you have any questions about this letter please contact Director, Compliance Branch at (781) 587-7484.
 
Sincerely,
/S/
Mutahar S. Shamsi
District Director
New England District
 
cc:
Kristin Haas, D.V.M., Director and State Veterinarian
Division of Food Safety and Consumer Protection
Vermont Agency of Agriculture, Food and Markets
116 State Street
Montpelier, Vermont 05620
 
(b)(4) 
            
Haroon Mian
USDA/FSIS District Office
District 65
230 Washington Ave.
Albany, New York 12203