Public Health Service
Food and Drug Administration
Baltimore District Office
6000 Metro Drive
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5705
March 8, 2016
Mr. Allen Douglas Galt, Co-Owner
High Hopes Farms, PTSP
7251 Pentridge Lane
Chestertown, MD 21620
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).
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 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 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 firstname.lastname@example.org.