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  5. Pearson, Eric J. - 01/21/2015
  1. Compliance Actions and Activities

WARNING LETTER

Pearson, Eric J. Jan 21, 2015

Pearson, Eric J. - 01/21/2015

Product:
Animal & Veterinary

Recipient:
Pearson, Eric J.


United States

Issuing Office:
Philadelphia District Office

United States


   

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

Public Health Service
Food and Drug Administration
  PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
15-PHI-09
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
January 21, 2015
 
Mr. Eric J. Pearson, Producer/Dealer
39 Phillips Road
Springville, Pennsylvania 18844-7562
 
Dear Mr. Pearson:
 
On October 15, 16, and 21, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your veal calf operation located at 39 Phillips Road, Springville, Pennsylvania. 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 animals for slaughter as food that were 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:
 
1.    On or about March 31, 2014, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about April 1, 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 penicillin at 1.569 parts per million (ppm) and neomycin at 12.3 ppm in the kidney. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.510 (21 C.F.R. 556.510). FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in 21 C.F.R. 556.430(b)(1). However, this tolerance does not apply to the use of Neomycin Oral Solution, ANADA 200-379, in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of Neomycin Oral Solution, ANADA 200-379, 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).
 
2.    On or about June 11, 2014, you sold a bob veal calf, identified with ear tag (b)(4), for slaughter as food. On or about June 13, 2014, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of neomycin at 33.98 ppm 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 21 C.F.R. 556.430(b)(1). However, this tolerance does not apply to the use of Neomycin Oral Solution, ANADA 200-379, in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of Neomycin Oral Solution, ANADA 200-379, 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 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 drug Neomycin Oral Solution, ANADA 200-379. Specifically, our investigation revealed that you did not use Neomycin Oral Solution, ANADA 200-379, as directed by its approved labeling. Use of this drug in this manner is an extralabel use, as defined at 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 Neomycin Oral Solution, ANADA 200-379, to your bob veal calves without following the animal class as stated in the approved labeling. Your extralabel use of Neomycin Oral Solution, ANADA 200-379, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Neomycin Oral Solution, ANADA 200-379, resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of Neomycin Oral Solution, ANADA 200-379, 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).
 
In addition, you adulterated the medicated feed consisting of cow’s milk mixed with Neomycin Oral Solution, ANADA 200-379, within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you fed this medicated feed to your bob veal calves. Your feeding of this medicated feed without following its prohibited use as directed by the approved labeling of Neomycin Oral Solution, ANADA 200-379, 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/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.
 
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 Ms. Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Rivers at (215)717-3076 or e-mail at robin.rivers@FDA.HHS.GOV.
 
Sincerely,
/S/ 
Anne E. Johnson
Acting District Director
Philadelphia District Office 

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