FDA to Hold Company Executives Responsible for Quality Issues

Recent FDA warnings that it will hold executives accountable for companies’ violations signify “somewhat of a change in philosophy” for the agency as it works to identify and publicize industry-wide quality issues sooner. The agency expects clear and open communication from corporate officials, particularly if a problem that could impact public health is identified, Deborah Autor, director of the Office of Compliance at the Center for Drug Evaluation and Research, said at FDAnews’ Fifth Annual FDA Inspections Summit.
Devices & Diagnostics Letter