A Softer, Gentler FDA Inspectorate? It’s Possible With QSR/ISO 13485 Harmonization, Auditing Expert Says

Let’s be blunt: Device-makers aren’t particularly fond of facility inspections by the US FDA. From audits that can sometimes drag on for weeks to nightmarish inspections well-documented by industry experts, there’s no shortage of tales of investigators that were difficult to handle. But the agency’s ongoing rewrite of its Quality System Regulation to harmonize it with international standard ISO 13485 could “soften FDA’s inspectorate,” NSF International’s Brian Ludovico says. Also: How might the FDA’s Quality System Inspection Technique (QSIT) change, post-harmonization?