A maker of low-level LED light-therapy devices was cited by the US FDA for premarket, quality systems and Medical Device Reporting violations. It's just one of two device-related warning letters released by the agency this week.

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this sixth installment of a 10-part series, experts David Elder and John McKay address communication between the front room – where investigators do the majority of their work – and the back room, used by company workers to fulfill investigator requests for documents, records and other information.

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this fifth installment of a 10-part series, the experts address so-called front rooms used by manufacturers during an inspection.