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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

CLEDALE 11/19/13

  

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

Public Health Service
Food and Drug Administration
 Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513 679-2700
        FAX: (513) 679-2761 

 

November 19, 2013                                                   
 
WARNING LETTER
CIN-14-412783-04
 
Via United Parcel Service
 
Edgar A. Cox, Owner
CLEDALE
33771 State Route 643
Fresno, Ohio 43824
 
Dear Mr. Cox:
 
On August 28 and September 6, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 33771 State Route 643, Fresno, Ohio. 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 December 31, 2012, you sold a bob veal calf, identified with back tags (b)(4) and (b)(4), for slaughter as food. On or about January 3, 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 9.64 parts per million (ppm) of neomycin in the kidney. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.430(b)(1) (21 C.F.R. 556.430(b)(1)).  However, this tolerance does not apply to the use of McNess - Acidified Stress Milk Replacer NT 1600 - Medicated (containing neomycin sulfate and oxytetracycline) in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of McNess - Acidified Stress Milk Replacer NT 1600 - Medicated (containing neomycin sulfate and oxytetracycline) in veal calves (pre-ruminating calves).  Therefore, the presence of this drug in kidney 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 neomycin and oxytetracycline that were contained in the McNess - Acidified Stress Milk Replacer NT 1600 - Medicated (containing neomycin sulfate and oxytetracycline).  Specifically, our investigation revealed that you did not use McNess - Acidified Stress Milk Replacer NT 1600 - Medicated (containing neomycin sulfate and oxytetracycline) as directed by its approved labeling. Use of these drugs in this manner is an extra-label use, as defined under 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 McNess - Acidified Stress Milk Replacer NT 1600 - Medicated (containing neomycin sulfate and oxytetracycline) to your bob veal calf, identified with back tags (b)(4) and (b)(4), without following the animal class as stated in the approved labeling. Your extralabel use of McNess - Acidified Stress Milk Replacer NT 1600 - Medicated (containing neomycin sulfate and oxytetracycline) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of McNess - Acidified Stress Milk Replacer NT 1600 - Medicated (containing neomycin sulfate and oxytetracycline) resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of McNess - Acidified Stress Milk Replacer NT 1600 - Medicated (containing neomycin sulfate and oxytetracycline) was not in conformance with its 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).
 
In addition, you adulterated McNess - Acidified Stress Milk Replacer NT 1600 - Medicated (containing neomycin sulfate and oxytetracycline) within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you failed to use the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Section 512 of the FD&C Act, 21 U.S.C. § 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feeds.
 
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 Mark E. Parmon, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Parmon at 513-679-2700, ext. 2162 or mark.parmon@fda.hhs.gov.
 
Sincerely,
/s/ 
Paul J. Teitell
District Director
Cincinnati District