Inspections, Compliance, Enforcement, and Criminal Investigations
Asociation de Productores de Leche Camuy-Quebradillas 13-Jun-05
Department of Health and Human Services
Public Health Service
San Juan District
June 13, 2005
Return Receipt Request
Mr. Francisco Torres Quijano
President of the Board
Asociacion de Productores de Leche Camuy-Quebradillas
HC 05 Box 27500
Camuy, PR 00627
Dear Mr. Torres:
On December 16 and 20, 2004, an Investigator from our office conducted an inspection, of your veterinary drug distribution facility located at Road 119 km 9.2, Barrio Cienaga, Carnuy, Puerto Rico. That inspection revealed that your firm is selling and dispensing prescription animal drug products without a lawful order from a licensed veterinarian. Because your firm dispensed prescription animal drugs without a lawful written or oral order from a licensed veterinarian, while held for sale they are misbranded within the meaning of Section 503(f)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act). Examples of prescription animal drugs your firm dispensed without an order from a licensed veterinarian include: gonadorelin diacetate tetrahydrate sterile solution (Cystorelin 50 mcg/ml), dinoprost tromethamine injection (Lutalyse 5 mg/ml), and isoflupredone acetate sterile aqueous suspension (Predef 2X 2mg/ml).
In addition, the prescription animal drugs dispensed by your firm are misbranded within the meaning of section 502(f)(1) of the Act in that they do not bear adequate directions for use and they do not fall into an exception to that requirement. FDA has defined "adequate directions for use" as "directions under which a layperson can use a drug safely for the purposes for which it is intended." Title 21 Code of Federal Regulations, Section 201.5 (21 CFR 201.5). Directions under which a layperson can safely use prescription animal drugs cannot be written because such drugs can only be used safely under the professional supervision of a licensed veterinarian. Thus, adequate directions for lay use cannot be written for these prescription animal drugs. These drugs are not exempt from Section 502(f)(1) because they fail to comply with the conditions set forth in Section 503(f)(2) and 21 CFR 201.105 in that they were not sold by or upon the lawful written or oral order of a licensed veterinarian in the course of the veterinarian's professional practice.
We acknowledge receipt of your response dated December 24, 2004 which proposes corrective actions to the Inspectional Observations reported to you on the form FDA-483 on December 20, 2004. Our evaluation of your response finds it to be inadequate because it does not specify the steps that your firm will be taking to avoid recurrence of' the violation. Instead, it simply requests FDA assistance in providing training to store employees.
The above is not intended to be an all-inclusive list of violations. You are responsible for complying with the requirements of the Act. You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, including but not limited to, seizure and/or injunction.
Please notify this office in writing, within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent the recurrence of similar violations. Also include copies of any available documentation demonstrating that corrections have been made. If corrective action can not be completed within 15 working days, state the reasons for the delay and the time period within which corrections will be completed. You should address your reply to this letter to Rafael Nevarez, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223.
San Juan District