Fuller Family Dairy, LLC 12/9/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New York District 158-15 Liberty Avenue Jamaica, NY 11433

December 9, 2010

WARNING LETTER NYK-2012-05

VIA UNITED PARCEL SERVICE

Joseph Fuller, Majority Owner
Fuller Family Dairy, LLC
1002 Elm Street Ext
Groton, New York 13073-9472

Dear Mr. Fuller:

On September 29 and October 4, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1002 Elm Street Ext, Groton, New York. 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 the 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 February 7 and 14, 2011, you sold a bob veal calf each day, identified with the sale tags numbered (b)(4), respectively, for slaughter as food. On or about February 8 and 15, 2011, (b)(4) located in (b)(4), slaughtered these animals. Our investigation also revealed that on or about December 27, 2010, you sold a bob veal calf, identified with the sale tag numbered  (b)(4) for slaughter as food. On or about December 28, 2010, (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 each of these animals identified the presence of the following violative residues: 

TAG ID	Slaughter Date	Residue	Tolerance	Drug
Bob Veal Calf (b)(4)	2/15/11	4.5 ppm Muscle  2.97 ppm Kidney	0.00 0.00	Penicillin Penicillin
Bob Veal Calf (b)(4)	2/8/11	1.03 ppm Kidney	0.00	Penicillin
Bob Veal Calf (b)(4)	12/28/10	5.16 ppm Muscle 5.07 ppm Kidney	0.00 0.00	Penicillin Penicillin

Note: FDA has established tolerance of 0.05 parts per million (ppm) for residues of penicillin in the edible tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.510 (21 C.F.R. 556.510). However, this tolerance does not apply to the use of  (b)(4) (penicillin-dihydrostreptomycin in oil) in bob veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of (b)(4) (penicillin-dihydrostreptomycin in oil) in bob veal calves (pre-ruminating calves). Therefore, the presence of this drug in kidney 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 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 complete 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 (b)(4) (penicillin-dihydrostreptomycin in oil) and (b)(4) (penicillin G procaine). Specifically, our investigation revealed that you did not use (b)(4) (penicillin-dihydrostreptomycin in oil) and (b)(4) (penicillin G procaine) drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use within the meaning of 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 the by-prescription-only (b)(4) (penicillin-dihydrostreptomycin in oil) mixed in your cow’s colostrum to your bob veal calves without following the labeled prohibition to not serve as food a cow’s colostrum for (b)(4) hours (b)(4) (milkings) after calving as stated in the approved labeling and your servicing veterinarian’s prescription. Your extralabel use of (b)(4) (penicillin-dihydrostreptomycin in oil) was in or on feed, in violation of 21 C.F.R. 530.11(b) and your extralabel use of (b)(4) (penicillin-dihydrostreptomycin in oil) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d).

Our investigation also found that you administered (b)(4) (penicillin G procaine) to your dairy cows without following the dose, route of administration, and injection site limitation. Your extralabel use of (b)(4) (penicillin G procaine) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). 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 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).

In addition, you adulterated your dairy cow’s medicated colostrum within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you fed this medicated feed to your bob veal calves. Your feeding of this medicated feed without following its prohibited use as directed by the approved labeling of (b)(4) (penicillin-dihydrostreptomycin in oil) caused this medicated feed to be unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Section 512 of the FD&C Act, 21 U.S.C. § 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feeds.

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 Dean R. Rugnetta, 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 Dean Rugnetta at (716) 541-0324 or E-mail at dean.rugnetta@fda.hhs.gov.

Sincerely,

/s/

Ronald M. Pace
District Director
New York District