Animal & Veterinary
First Debarment For Violation Of Veterinary Drug Regulations
March 14, 2000
The Food and Drug Administration (FDA) has issued a final order permanently debarring Premchand Girdhari, Eau Claire, WI, from providing services in any capacity to a person who has an approved or pending drug product application. FDA based this order on a finding that Mr. Girdhari was convicted of two felonies under Federal law relating to the regulation of a drug product under the Federal Food, Drug, and Cosmetic Act (the Act). This is the first debarment resulting from violations of the Act involving veterinary drugs.
The factual basis underlying Mr. Girdhari's debarment relates to his 1991 guilty plea to making false statements and distributing adulterated drugs with the intent to defraud and mislead in violation of the Act. Mr. Girdhari is the President of Radix Laboratories, Inc., a firm that manufactured a variety of animal drugs. He marketed the drug "Antihistamine (2%)," which was adulterated under the Act because it was not the subject of the necessary FDA approvals nor was it manufactured in conformity with good manufacturing practice. He also knowingly and willfully made a false statement related to FDA's regulation of the injectable animal drug, "Cal-Plex."
Section 306(a)(2) of the Act mandates debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the regulation of any drug product under the Act.
Additional information about this debarment is contained in the January 21, 2000, Federal Register, and from Richard L. Arkin, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0141, FAX 301-827-5510, e-mail firstname.lastname@example.org.