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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Martin, Marlin 3/7/14

  

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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313-393-8100
FAX: 313-393-8139 

 

WARNING LETTER
2014-DET-06
 
March 7, 2014
 
VIA UPS
 
Mr. Marlin I. Martin, Co-Owner
Mrs. Anita Martin, Co-Owner
Martin, Marlin
7394 South Miner Road
Carson City, Michigan 48811-9534
 
Dear Mr. and Mrs. Martin:
 
On January 13, 24 and February 13, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 7394 South Miner Road, Carson City, Michigan. 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 June 11, 2013, you sold a dairy cow, identified with back tag (b)(4) (ear tag (b)(4)) for slaughter as food. On June 12, 2013, (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 12.07 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.113(b)(3)(i), [21 C.F.R. 556.113(b)(3)(i)]. 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 and to identify and segregate treated animals. 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 drug Naxcel (ceftiofur sodium sterile powder, NADA #140-338). Specifically, our investigation revealed that you did not use Naxcel 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). 
 
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 Naxcel to your dairy cows without following the indications for use as stated in its approved labeling. Your extralabel use of Naxcel 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 Naxcel to your dairy cows without following the frequency of the treatment as stated in its approved labeling. Naxcel is prohibited for extralable use in cattle by 21 C.F.R. 530.41(a)(13)(ii). 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).
 
The above is not intended to be an all-inclusive list of violations. As a dealer 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.
 
We acknowledge receipt of your response to the FDA-483, Inspectional Observations, dated February 23, 2014.  Your response states you will try to improve your treatment records and mark all treated cows and cows with meat holds with leg bands and/or bright tape.  We find your response to be inadequate because you have not provided any documentation supporting your proposed corrective actions.  For example, your response did not include a copy of your new treatment records.  Additionally, your response did not include any corrective actions related to the extralabel use of Naxcel without the supervision of a licensed veterinarian.    
 
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 CDR Kimberly Martin, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207.
 
If you have any questions about this letter, please contact CDR Martin at (317) 226-6500 ext. 116 or email at kimberly.martin@fda.hhs.gov.
 
Sincerely,
/S/
Glenn T. Bass
District Director
Detroit District Office