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 eighth installment of a 10-part series, the experts urge firms to ask questions of the FDA’s inspection team.

More than 9 million surgical gowns used in many everyday surgical procedures, including open heart surgery and knee replacements, have been recalled because of sterility concerns. Cardinal Health Inc. has placed the blame on a contract manufacturer that made the gowns in "unapproved locations that did not maintain proper environmental conditions."

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 seventh installment of a 10-part series, the experts address the use of SMEs – subject matter experts – during inspections.

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.

Three patients have filed suit against Medtronic in recent weeks alleging they were injured by malfunctioning surgical staplers made by the company. The lawsuits add to recent scrutiny of the device type’s safety.

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.

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 fourth installment of a 10-part series, the experts address so-called back rooms used by manufacturers during an inspection.

The US agency is telling health-care providers to yank specific gowns – and procedural packs that contain the gowns – from shelves because their maker, Cardinal Health Inc., cannot assure their sterility. The agency is also warning that the problem could lead to a shortage of so-called Level 3 gowns, which are used in a wide-array of everyday surgical procedures.