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The complaint aims to stop the company from manufacturing and distributing animal drugs in conditions unsatisfactory to the minimum regulatory requirements to ensure safety and quality.
On Oct. 27, 2020, the United States filed a civil complaint against Med-Pharmex (MPX), a Pomona, CA-based animal health company, regarding its manufacturing and distribution of adulterated animal drugs.
According to a press release from the Department of Justice, the complaint aims to stop the company from manufacturing and distributing animal drugs in conditions unsatisfactory to the minimum regulatory requirements to ensure safety and quality. In the complaint, it is noted that FDA inspected the company site several times, which resulted in a warning letter in 2017 that noted deficiencies at the company including the failure to properly clean and disinfect areas used to manufacture sterile drugs and the failure to conform to current good manufacturing practices. Additionally, the complaint also mentions MPX’s failure to sufficiently examine reports of the death or illness of animals receiving MPX drugs, the press release said.
“Americans depend on animal drugs being safe and effective,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division, in the press release. “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,” added FDA Chief Counsel Stacy Amin, in the press release. “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.”
Source: Department of Justice