Washington, DC - The United States filed a civil complaint to stop a California company from manufacturing and distributing adulterated animal drugs, the Department of Justice announced.
The complaint, filed October 27, seeks a permanent injunction against defendants Med-Pharmex, Inc. (MPX), Gerald P. Macedo, and Vinay M. Rangnekar to prevent them from manufacturing and distributing animal drugs under conditions that fall short of the minimum regulatory requirements to ensure safety and quality. The complaint alleges that multiple inspections by the U.S. Food and Drug Administration (FDA) repeatedly showed that the defendants failed to conform to current good manufacturing practices (cGMPs), including failure to maintain sterility.
“Americans depend on animal drugs being safe and effective,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division. “We will continue working with FDA to ensure all drug manufacturers abide by public safety requirements.”
“Ensuring FDA-approved animal medications are safe, effective and manufactured using current good manufacturing practices is an important part of the FDA’s mission to protect human and animal health,” said FDA Chief Counsel Stacy Amin. “The FDA will continue to pursue actions against those who put animal patients in harm’s way by manufacturing and distributing adulterated animal drug products.”
According to the complaint, FDA issued a warning letter to MPX in 2017 regarding numerous deficiencies at the company. The complaint further alleges that the company failed to adequately investigate reports regarding the death or illness of animals receiving Med-Pharmex drugs. The complaint also alleges that FDA inspections revealed the company failed to properly clean and disinfect areas used to manufacture sterile drugs. The Justice Department filed the complaint in U.S. District Court for the Central District of California at the request of FDA.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.
The case is being handled by Trial Attorney Rachel E. Baron of the Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel James C. Fraser of the FDA’s Office of the Chief Counsel.