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FDA Commissioner Stephen Hahn offered more details yesterday of the agency’s plans to request paper records from Chinese drugmakers and API manufacturers while inspections in China are on hold during the COVID-19 outbreak. Read More
The FDA hit a South Korean drug manufacturer for serious violations at its Chuncheon, Gangwon facility, including lax investigations and testing deficiencies. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) wrote up a drug manufacturer in Bangalore, India for data integrity and other serious violations observed during a December 13 inspection. Read More
The FDA slapped a German contract manufacturer with a Form 483 for serious data integrity violations found in an inspection of its facility in Bavaria. Read More
The FDA and the government of India stopped hundreds of shipments of illicit prescription drugs and combination products from entering the U.S. during their first joint enforcement operation, the two regulators announced yesterday. Read More
The firm also strayed from its batch manufacturing instructions, allowing a bulk batch that was out-of-specification to get passing results for viscosity and density, the agency said. Read More
In its response to the inspection findings, the company said it would begin sending all batches to the lab for analysis prior to distribution. Read More