FDA Investigators Play Fast And Loose With Quality System Inspection Technique, Experts Say – But Is It Par For The Course?
• By Shawn M. Schmitt
US FDA’s Quality System Inspection Technique – or QSIT – isn’t being followed to the “T” by many agency investigators, say industry experts, including two who authored the auditing approach in 1999. Sources tell Medtech Insight that QSIT, designed to ensure that investigators look at the most important compliance issues and ask pertinent questions linked to four major quality system subsystems, is routinely bypassed by investigators bent on inspecting their own way. But it’s not unreasonable for investigators to deviate from QSIT as they follow leads wherever they may go, says a former director of FDA’s Investigations Branch who left the agency in June. Meanwhile, a key player in the development of the Quality System Inspection Technique, Tim Wells, explains why he’s drafting a “new” QSIT for industry use.
Two authors of US FDA’s Quality System Inspection Technique say too many agency investigators aren’t always following the auditing approach when conducting facility inspections, often catching device manufacturers by surprise as they manage onsite FDA audits.
The claims come as one of the authors – Tim Wells – says QSIT is outdated and desperately needs a facelift; he is in the process of creating his own updated version of
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.
States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.
Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.
Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.
