| Public Health Service Food and Drug Administration |
| 555 Winderley Pl., Ste. 200 Maitland, Fl 32751 |
Department of Health and Human Services
WARNING LETTER
FLA-10-16
April 21, 2010
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Rodney R. Land
Owner
Land Dairy, Inc.
952 NE County Road 361
Mayo, Florida 32066-5419 U.S.A.
Dear Mr. Land,
On January 13, 2010 through January 14, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 952 NE County Road 361, Mayo, Florida. 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. Further, under section 402(a)(4) of the 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 August 6, 2009, you hauled and sold a dairy cow, identified with a miscellaneous metal tag (b)(4) USDA Retain 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 0.2 parts per million (ppm) sulfamethazine in the liver tissues. FDA has not established a tolerance for residues of sulfamethazine in the edible tissues of lactating dairy cows. 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).
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, you failed to maintain records documenting the identity of the dairy cows that you transported and delivered for sale at (b)(4) on or about August 6, 2009, and you failed to establish and maintain an inventory system for determining the quantities of drugs used to medicate your dairy cows. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
We also found that you adulterated the new animal drug sulfamethazine (NADA 120-615). Specifically, our investigation revealed that you did not use sulfamethazine as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See Title 21, Code of Federal Regulations, Section 530.3(a), (21 C.F.R. § 530.3(a)).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the 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 sulfamethazine oral boluses to female dairy cattle twenty (20) months of age or older contrary to the approved labeling. Sulfamethazine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. § 530.41(a)(9) and your extralabel use of sulfamethazine 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).
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 Salvatore N. Randazzo, Compliance Officer, U.S. Food and Drug Administration, Florida District Office, 555 Winderley Place, Suite 200, Maitland, Florida 32751-7140. If you have any questions about this letter, please contact Compliance Officer Randazzo at (407) 475-4712 or by email at salvatore.randazzo@fda.hhs.gov.
Sincerely yours,
/S/
Emma R. Singleton
District Director
Florida District
Enclosure-21 C.F.R. Part 530
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