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  5. Gerratt Dairy - 12/15/2014
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WARNING LETTER

Gerratt Dairy Dec 15, 2014

Gerratt Dairy - 12/15/2014

Product:
Animal & Veterinary

Recipient:
Gerratt Dairy


United States

Issuing Office:
Seattle District Office

United States


   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Seattle District
Pacific Region
22215 26th Ave SE, Suite 210
Bothell, WA 98021-4425
 
Telephone:      425-302-0340           
FAX:            425-302-0402

 

December 15, 2014
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
In reply refer to Warning Letter SEA 15-07
 
Dale W. Gerratt, Owner
Gerratt Dairy
1400 South 2200 East
Hazelton, Idaho 83335-5600
 
WARNING LETTER
 
Dear Mr. Gerratt:
 
On September 15-17, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1350 South 2250 East, Hazelton, Idaho 83335. 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.
 
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 FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 February 18, 2014, you sold a dairy cow identified with ear tag (b)(4), back tag (b)(4), and retain tag (b)(4) for slaughter as food. On or about February 18, 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 0.17 parts per million (ppm) of ampicillin in the kidney tissue. FDA has established a tolerance of 0.01 ppm for residues of ampicillin in the uncooked edible tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.40, 21 C.F.R. 556.40. 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 FD&C 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. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
 
We also found that you adulterated the new animal drugs Polyflex (Ampicillin, Injectable Suspension, NADA #055-030), Di-Methox (Sulfadimethoxine Injection 40%, Antibacterial, ANADA #200-038), Tetroxy-LA (Oxytetracycline, Injectable, ANADA #200-117), and Excede (Ceftiofur Crystalline Free Acid, Sterile Suspension, NADA #141-209). Specifically, our investigation revealed that you did not use Polyflex, Di-Methox, Tetroxy-LA, and Excede as directed by their approved label or by the servicing veterinarian’s prescription. Use of these drugs in this manner is an extralabel use. See 21 C.F.R. 530.3(a). We have enclosed a copy for your reference.
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel 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 Polyflex (Ampicillin, Injectable Suspension, NADA #055-030) to your dairy cow, ear tag (b)(4), back tag (b)(4), and retain tag (b)(4), without following the dose set forth in the approved product labeling. Your extralabel use of Polyflex was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Polyflex resulted in illegal residues, in violation of 21 C.F.R. 530.11(d). 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 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
 
Our investigation found that you administered Di-Methox (Sulfadimethoxine Injection 40%, Antibacterial, ANADA #200-038), to your lactating dairy cows without following the dose set forth in the approved product labeling. Your extralabel use of Di-Methox was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). In addition, sulfonamide drugs, which include sulfadimethoxine, are prohibited by 21 CFR 530.41(a)(9), for extralabel use in lactating dairy cattle.
 
Our investigation found that you administered Tetroxy-LA (Oxytetracycline, Injectable, ANADA #200-117) to your lactating dairy cows without following the dose and species class (i.e. not for use in lactating dairy animals) as set forth in the approved product labeling. Your extralabel use of Tetroxy-LA was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).
 
Our investigation found that you administered Excede (Ceftiofur Crystalline Free Acid, Sterile Suspension, NADA #141-209) to your lactating dairy cows without following the dose as set forth in the approved product labeling. Your extralabel use of Excede was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).  In addition, the use of a cephalosporin, by not following the approved labeled dosage rate, is prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(13)(ii). 
 
Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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 501(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 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 Patricia A. Pinkerton, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4425. If you have any questions about this letter, please contact Compliance Officer Patricia A. Pinkerton at (425) 302-0428.
 
Sincerely,
/S/ 
Miriam R. Burbach
District Director