Inspections, Compliance, Enforcement, and Criminal Investigations
Jose Diego Diaz Inc 5/25/04
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|466 Fernandez Juncos Avenue|
San Juan, Puerto Rico, 00901
May 25, 2004
RETURN RECEIPT REQUESTED
Mr. Fernando Diaz
Jose Diego Diaz. Inc.
Road # 130, Km. 4.9
P.O. Box 1333
Hatillo, Puerto Rico 00659
Dear Mr. Diaz,
Recently an inspection was made of your veterinary drug distribution facility located at Road #130, Km 4.9, Hatillo, Puerto Rico. This inspection was conducted on November 21 and December 18, 2003, by a Food and Drug Administration (FDA) investigator from this office who documented the sales of prescription veterinary drugs, such as (b)(4) and (b)(4) without requiring a written prescription or oral order from a licensed veterinarian. Under Section 503(f)(1)(C) of the Federal Food, Drug and Cosmetic Act, the dispensing of a prescription drug other than by or upon the lawful written or oral order of a licensed veterinarian results in the drug being misbranded.
In addition, the prescription drugs dispensed by your firm are misbranded within the meaning of section 502(f)(1) because they lack adequate directions for use. Pursuant to Title 21, Code of Federal Regulations, section 201.5, "adequate directions for use" means adequate directions under which the layman can use a drug safely and for the purposes for which it was intended. Such adequate directions for use by laypersons cannot be written for prescription drugs because the drugs can only be used safely at the direction of, and under the supervision of, a licensed veterinarian.
The corrective action of posting a sign with a list of prescription veterinary drugs that require a veterinarian's prescription does not appear to be adequate. During the inspection of your firm, the FDA Investigator observed your employee selling (b)(4) and (b)(4) Injection without requiring a written prescription or oral order from a licensed veterinarian. In addition, photographs of your firm's product inventory showed that (b)(4) and (b)(4) for Injectable Suspension) where being held for sale. These two products are prescription veterinary drugs and they do not appear on the sign posted by your firm.
You should take prompt action to correct these violations and to establish procedures to prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice. such as seizure and/or injunction.
The violations listed above are not intented to be an all-inclusive list. As a corporate official of this firm, you have a responsibility to ensure that all drugs sold by you or other employees of your firm comply with all state and federal laws.
It is necessary that you take action on this matter now. Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the steps you are taking to correct the problems and bring your firm into compliance with the law. Your response should include each step being taken, or that will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, please state the reason for delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demostrating that corrections have been made.
Your reply should be directed to the Food and Drug Administration (Attention: Carlos A. Medina, Compliance Officer) at the above address. If you have any questions concerning the deficiencies noted, you may contact Compliance Officer Carlos A. Medina at 787-474-9538.