Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/high-hopes-farms-ptsp-03082016
Timestamp: 2019-08-21 22:52:22
Document Index: 422957758

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

High Hopes Farms, PTSP - 03/08/2016 | FDA
High Hopes Farms, PTSP - 03/08/2016
High Hopes Farms, PTSP Mar 08, 2016
High Hopes Farms, PTSP
CMS #488386
Mr. Allen Douglas Galt, Co-Owner
7251 Pentridge Lane
Dear Mr. Galt:
On December 9th and 11th, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dairy operation, High Hopes Farms, PTSP, located at 7501 Broad Neck Road, Chestertown, MD, 21620. This letter notifies you of the violations of the Federal Food, Drug and Cosmetic Act (the FD&C Act) that we found during our inspection 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 adulterated the new animal drug ALBON (Sulfadimethoxine, 5g bolus, NADA #31- 715). Specifically, our inspection revealed that you did not use ALBON as directed by its approved labeling. Use of this drug in this manner is an extra label use. See Title 21, Code of Federal Regulations, Section 530.3(a) (21 C.F.R. § 530.3(a)).
The extra label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra label 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 ALBON (Sulfadimethoxine, 5g bolus, NADA #31-715) to your bob veal calf, identified with back tag # (b)(4), without following the animal class as stated in the approved labeling. Your extra label use of ALBON was not under the supervision of a licensed veterinarian, in violation of21 C.F.R. § 530.1l(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 50l(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
You should take prompt action to correct 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.
Your written response should be sent to Ms. Evelyn Bonnin, District Director, Food & Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have any questions regarding this letter, please contact CDR Rochelle B. Young, RPh, MSA, Compliance Officer, at 410-779-5437 or rochelle.young@fda.hhs.gov.
Laurie Bucher, Chief
13 60 Marshall Street