• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Vaill Brothers 7/30/10

  

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

Public Health Service
Food and Drug Administration
 

New York District
158-15 Liberty Avenue
Jamaica, NY 11433

July 30, 2010

WARNING LETTER NYK 2010-25

VIA UNITED PARCEL SERVICE

Milton Vaill, Owner
Vaill Brothers
Route 26, Box 333a
Vernon, New York 13476

Dear Mr. Vaill:

On April 19, 21, and 23, 2010 the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 4549 Route 26, Vernon, New York. 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 the FDA's web page at www.fda.gov.

We found you offered for sale animals which were slaughtered as food and were 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 August 12, 2009, you sold a dairy cow, identified with farm tag (b)(4) and back tag (b)(4), for slaughter as food. On or about August 13, 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 penicillin in the kidney at 0.12 parts per million (ppm) and sulfadimethoxine in the liver at 0.199 ppm. FDA has established tolerances of 0.05 ppm for residues of penicillin in the uncooked edible tissue of cattle as codified in Title 21, Code of Federal Regulations, Section 556.510 (21 C.F.R. 556.510) and for residues of sulfadimethoxine in the uncooked edible tissues of cattle at 0.1 ppm as codified in 21 C.F.R. 556.640. The presence of these drugs in 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 Act [21 U.S.C. 342(a)(2)(C)(ii)].

In addition, our investigation revealed that on or about October 5, 2009, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about October 6, 2009, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of neomycin in the kidney at 9.31 ppm. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in 21 C.F.R. 556.430(b)(1). However, this tolerance does not apply to use of Advance CALVITA Supreme Medicated All Milk - Calf Milk Replacer containing oxytetracycline and neomycin in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with use of Advance CALVITA Supreme Medicated All Milk - CalfMilk Replacer containing oxytetracycline and neomycin in veal calves (pre-ruminating calves). Therefore, the presence of this drug in kidney 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 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 [21U.S.C.342(a)(4)].

We also found that you adulterated the new animal drugs Pen-Aqueous (penicillin G procaine), NADA 65-010; Di-Methox (sulfadimethoxine injection 40%), ANADA 200-038; Hetacin-K (hetacillin potassium), NADA 55-054; and ToDAY (cephapirin sodium), NADA 97-222. Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an 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 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 CFR 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 Pen-Aqueous (penicillin G procaine), NADA 65-010, to the dairy cow, identified with farm tag (b)(4) and back tag (b)(4), without following the dose, site limitations, duration of treatment, and indications of use as stated in the approved labeling. Your extralabel use of Pen-Aqueous (penicillin G procaine), NADA 65-010, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a) and your extralabel use of Fen-Aqueous (penicillin G procaine), NADA 65-010, resulted in illegal drug residue, in violation of 21 C.F.R. 530.11(d).

Our investigation found that you administered Di-Methox (sulfadimethoxine injection 40%), ANADA 200-038, to the dairy cow, identified with farm tag (b)(4) and back tag (b)(4), without following the route of administration and indications of use as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d).

Our investigation found that you administered Hetacin-K (hetacillin potassium), NADA 55-054, to the dairy cow, identified with farm tag (b)(4) and back tag (b)(4), without following the frequency of treatment as stated in the approved labeling. Your extralabel use of Hetacin-K. (hetacillin potassium), NADA 55-054, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).

Our investigation found that you administered ToDAY(cephapirin sodium), NADA 97-222, to the dairy cow, identified with farm tag (b)(4) and back tag (b)(4), without following the frequency and duration of treatment as stated in the approved labeling. Your extralabel use of ToDAY (cephapirin sodium), NADA 97-222, 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 Advance CALVITA Supreme Medicated All Milk - CalfMilk Replacer containing oxytetracycline and neomycin to the bob veal calf, identified with back tag (b)(4), without following the animal class as stated in the approved labeling. Advance CALVITA Supreme Medicated All Milk - CalfMilk Replacer containing oxytetracycline and neomycin is prohibited for extralabel use in calves to be processed for veal by 21 C.F.R. 530.558(d)(4)(vi) and your extralabel use of Advance CALVITA Supreme Medicated All Milk - CalfMilk Replacer containing oxytetracycline and neomycin resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d).

Because your extralabel use of these drugs were 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)].

In addition, you adulterated Advance CALVITA Supreme Medicated All Milk - Calf Milk Replacer (oxytetracycline and neomycin) within the meaning of section 501(a)(6) of the Act [21 U.S.C. 351(a)(6)] when you failed to use the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe under section 512 of the Act [21 U.S.C. 360b]. Section 512 of the Act [21 U.S.C. 360b] and 21 C.F.R. 530.11(b)do not permit the extralabel use of medicated feeds.

On or about March 24, 2001, you provided (b)(4), with a signed certification, which states that you were not delivering to (b)(4) any livestock having illegal levels of drug residues. On or about August 12, 2009, you delivered a culled dairy cow containing violative levels of penicillin and sulfadimethoxine residues, and again, on or about October 5, 2009, you delivered a bob veal calf containing a violative level of neomycin residue to (b)(4). Pursuant to section 301 (h) of the Act [21 U.S.C. 331(h)], providing such a false guaranty is a prohibited act.

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 above violations and to establish procedures whereby such 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 Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A. Clark at 716-5514461,extension 3168.

Sincerely yours,

/s/


Ronald M. Pace
District Director
New York District