Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/smucker-samuel-01072015
Timestamp: 2019-08-24 16:56:38
Document Index: 149908774

Matched Legal Cases: ['§ 556', '§ 342', 'art 530', '§ 360', '§ 351', '§ 351', '§ 360', 'art 530']

Smucker, Samuel - 01/07/2015 | FDA
Smucker, Samuel - 01/07/2015
Smucker, Samuel Jan 07, 2015
Smucker, Samuel
15-PHI-07
Mr. Samuel J. Smucker, Owner
161 Nolt Road
Dear Mr. Smucker:
On October 8, 10, and 14, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 161 Nolt Road, Narvon, Pennsylvania. 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.
Specifically, our investigation revealed that on or about March 4, 2014, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about March 5, 2014, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the bob veal calf with back tag (b)(4) identified the presence of neomycin at 15.4 parts per million (ppm) in the kidney tissue. Our investigation also revealed that, on or about February 4, 2014, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about February 5, 2014, (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 neomycin at 12.3 ppm in the kidney tissue. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.430(b)(1) (21 C.F.R. § 556.430(b)(1)). However, this tolerance does not apply to the use of NT Concentrate (Neomycin Sulfate/Oxytetracycline, NDC-66104-8853) in calves to be processed for veal (pre-rumination calves), and there is no acceptable level of residue associated with the use of this drug 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 NT Concentrate (Neomycin Sulfate/Oxytetracycline, NDC-66104-8853). Specifically, our investigation revealed that you did not use NT Concentrate as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a).
Our investigation found that you administered NT Concentrate to a bob veal calf with back tag (b)(4) and to a bob veal calf with back tag (b)(4), a class of animal not set forth in the approved labeling. Your extralabel use of NT Concentrate was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R.530.11(a) and your extralabel use of NT Concentrate resulted in an illegal drug residue, in violation of 21 C.F.R.530.11(c). 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 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 the animal feed that you fed to your bob calves by adding the new animal drug NT Concentrate to the milk replacer , within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6). The extralabel use of drugs in or on animal feed is specifically prohibited by section 512(a)(4), 21 U.S.C. § 360b(a)(4), of the FD&C Act, and 21 C.F.R. Part 530.11(b).
Smucker, Samuel - Close Out Letter 12/7/15