| Public Health Service Food and Drug Administration |
| New England District One Montvale Avenue Stoneham, Massachusetts 02180 (781) 596-7700 FAX: (781) 596-7896 |
Department of Health and Human ServicesWARNING LETTER
NWE-15-10W
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
April 2, 2010
Mr. Raymond Wright, Partner
The Wright Place, LLC
77 Wright Road
Clinton, Maine 04927-3410
Dear Mr. Wright:
On November 17, 18, 25, and December 15, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 77 Wright Road, Clinton, Maine 04927-3410. 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. 360b.
Specifically, our investigation revealed that on or about August 4, 2009, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about August 6, 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 10.99 parts per million (ppm) of neomycin residue in the kidney. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430 (21 C.F.R. 556.430). However, this tolerance does not apply to use of Custom Calf White Plus NT Medicated Milk Dairy Herd and Beef Calf Milk Replacer in bob veal calves, and there is no acceptable level of residue associated with the use of this medicated milk replacer in veal calves. 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 Act, 21 U.S.C. § 342(a)(2)(C)(ii).
We also found that you adulterated the new animal drug neomycin sulfate. Specifically, our investigation revealed that you did not use neomycin sulfate as directed by its approved labeling. Use of this drug in this manner is an extralabel use. Please refer to 21 C.F.R. 530.3(a), a copy is enclosed for your reference.
Our investigation found that you fed Custom Calf White Plus NT Medicated Dairy Herd and Beef Calf Milk Replacer containing neomycin sulfate to the bob veal calf with back tag # (b)(4) without following the approved labeling. The extralabel use of Custom Calf White Plus NT Medicated Dairy Herd and Beef Calf Milk Replacer containing neomycin sulfate was in or on feed, in violation of 21 C.F.R. 530.11(b), and the extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because this use of Custom Calf White Plus NT Medicated Dairy Herd and Beef Calf Milk Replacer containing neomycin sulfate was not in conformance with the approved labeling, you caused the drug in the feed to be unsafe under section 512(a)(1) of the Act, 21 U.S.C. § 360b(a)(1), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. § 351(a)(5). In addition, you caused the animal feed containing the neomycin sulfate to be unsafe under section 512(a)(2) of the Act, 21 U.S.C. § 360b(a)(2), and adulterated within the meaning of section 501(a)(6) of the Act, 21 U.S.C. § 351(a)(6).
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 Lori Holmquist, Compliance Officer, U.S. Food and Drug Administration, 330 Civic Center Drive, Suite 1, Box 4, Augusta, Maine 04330. If you have any questions about this letter, please contact Compliance Officer Lori Holmquist at (207) 622-8268 x 13.
Sincerely yours,
/s/
John R. Marzilli
District Director
New England District
Enclosure
cc: Brian Wright, Partner
The Wright Place
77 Wright Road
Clinton, Maine 04927-3410
Steve Wright, Partner
The Wright Place
77 Wright Road
Clinton, Maine 04927-3410
cc: FSIS, TSC, State of Maine
No comments:
Post a Comment