• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Vaqueria Ruben Gonzalez 7/19/12

  

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

Public Health Service
Food and Drug Administration
 
San Juan District
Compliance Branch 
466 Fernández Juncos
San Juan, Puerto Rico 00901-3223
 
Telephone: 787-474-9500
FAX: 787-729-6658 

 

JUL 19, 2012
WARNING LETTER
12-SJN-WL-07
 
OVERNIGHT MAIL
 
Mr. Rubén González Echevarría
Owner
Vaquería Rubén González
P.O. Box 140194
Arecibo, Puerto Rico 00614-0194
 
Dear Mr. González:
 
On June 5, 8, and 15, 2012, we conducted an inspection of your dairy operation located at Road 490 Interior, Km 3.8, Barrio Atoarriba Sector Cuneta, Arecibo, Puerto Rico. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our inspection of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on the FDA’s web page at www.fda.gov.
 
Specifically, our inspection found that you adulterated the new animal drug Quartermaster® Suspension (penicillin-dihydrostreptomycin in oil) since you did not use Quartermaster® Suspension (penicillin-dihydrostreptomycin in oil) 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 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 inspection found that you administered the by-prescription-only Quartermaster® Suspension (penicillin-dihydrostreptomycin in oil) mixed in your cow’s colostrum (food) to your bob veal calf without following the labeled prohibition to not serve as food a cow’s colostrum for 96 hours (eight milkings) after calving as stated in the approved labeling. Your extra-label use of Quartermaster® Suspension (penicillin-dihydrostreptomycin in oil) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Quartermaster® Suspension (penicillin-dihydrostreptomycin in oil) was in or on feed, in violation of 21 C.F.R. 530.11(b) and your extralabel use of Quartermaster® Suspension (penicillin-dihydrostreptomycin in oil) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). 
 
Our inspection also found that you administered Quartermaster® Suspension (penicillin-dihydrostreptomycin in oil) to one of your dairy cows, identified with ear tag (b)(4), without following the approved labeling (i.e., treating the animal within 6 weeks of freshening). Your extra-label use of Quartermaster® Suspension (penicillin-dihydrostreptomycin in oil) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). 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).
 
In addition, you adulterated your dairy cow’s medicated colostrum 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 calf. Your feeding of this medicated feed without following its prohibited use as directed by the approved labeling of Quartermaster® Suspension (penicillin-dihydrostreptomycin in oil) 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 Ms. Maridalia Torres, District Director, at 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions about this letter, please contact Compliance Officer Carlos A. Medina at (787) 474-9538 or via email at carlosa.medina@fda.hhs.gov. 
 
Sincerely,
/s/
Maridalia Torres
District Director
San Juan District