Court Enjoins California Company from Manufacturing and Distributing Adulterated Sterile Animal Drugs | OPA

A federal court enjoined a California company from distributing adulterated sterile animal drugs in violation of the Federal Food, Drug and Cosmetic Act (FDCA), the Department of Justice announced.

In a complaint filed on Oct. 27, 2020 in the Central District of California, the United States alleged that multiple inspections by the U.S. Food and Drug Administration (FDA) repeatedly showed that Med-Pharmex Inc. (MPX) manufactured and distributed animal drugs under conditions that fell short of the minimum regulatory requirements to ensure safety and quality, including a failure to maintain sterility. According to the complaint, the FDA issued a warning letter to MPX in 2017 regarding numerous deficiencies found at the company. The complaint further alleged that the company failed to adequately investigate reports regarding the death or illness of animals receiving certain MPX drugs, and failed to properly clean and disinfect areas used to manufacture sterile drugs, as required by the FDCA. MPX and company president Gerald P. Macedo agreed to settle the suit and to be bound by a consent decree of permanent injunction that resolves the case.

“Companies that distribute animal drugs must abide by the FDCA and all applicable regulations to help ensure the safety of these products,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The department will continue to work closely with the FDA to enforce these important requirements.”

“Ensuring FDA-approved animal medications are safe, effective and manufactured using current good manufacturing practices is a crucial part of the FDA’s mission to protect human and animal health,” said Director Steven M. Solomon DVM, MPH, of the FDA’s Center for Veterinary Medicine. “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.”

The consent decree entered by the court requires, among other things, that the defendants refrain from manufacturing, processing, packing, holding and distributing any sterile drugs manufactured at MPX’s facilities, unless and until the FDA determines that the defendants’ sterile operations are in compliance with the court’s order, the FDCA and related regulations.  The consent decree also gives the FDA authority to order the defendants to take corrective actions with respect to both sterile and non-sterile products if additional violations are identified.       

The government was represented by Trial Attorney Rachel E. Baron of the Justice Department’s Consumer Protection Branch, with the assistance of Charlotte F. Hinkle and Michael Shane of the FDA’s Office of Chief Counsel. The U.S. Attorney’s Office for the Central District of California provided assistance.

Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.