As part of a plea agreement, Fresenius Kabi Oncology Ltd. will pay $30 million in fines, forfeit $20 million and plead guilty to a misdemeanor of concealing and destroying records prior to an FDA inspection. The company also agreed to implement a compliance and ethics program, according to the U.S. Department of Justice (DoJ). In preparation for a January 2013 inspection of its Kalyani, India, facility, which produced active pharmaceutical ingredients (APIs) for cancer drugs marketed in the U.S., plant management told employees to remove certain records from the premises and delete computer records that would have shown that its manufacture of the APIs didn’t meet FDA requirements. Consequently, employees deleted spreadsheets and removed computers, paper documents and other materials before the inspector arrived, the DoJ said.
Australia’s Therapeutic Goods Administration (TGA) unveiled its COVID-19 Vaccine Safety Monitoring Plan to strengthen its existing vaccine vigilance system. The new plan is intended to help the TGA manage emerging safety issues and help maintain public confidence in the COVID-19 immunization program. The plan stresses timeliness – in collecting and managing adverse event reports, detecting and investigating safety signals, addressing safety concerns, communicating with the public about the safety of the vaccines, and collaborating and coordinating with other vaccine safety stakeholder groups.