Quality Replay: FDA Urges Firms To Close Loop On CAPAs, Create Filters To Weed Out Poor Quality Data
From our digital archives: Applying a closed-loop approach to corrective and preventive action activities is one of the best ways to ensure device quality and gather useful data, US FDA says. Manufacturers often fail to ensure that they complete the CAPA loop, leading to corrective and preventive actions that might be open for years, or product fixes that don’t work and complicate matters further by presenting the firms with a whole new set of challenges.
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Compliance Corner: There Are 7 Reasons Why You're Screwing Up Management Reviews, Abbott Quality VP Says
Monica Wilkins, divisional VP of medical, quality and strategic support for device-maker Abbott Laboratories, lays out seven distinct issues that can keep manufacturers from getting the most out of management review meetings.
Warning Letter Nosedive: US FDA Writes Fewest Quality-Related Missives Since 2002; Agency Isn't Sure Why
Only 57 quality-related warning letters were issued to device manufacturers in 2016, a 14-year-low that has left US FDA scratching its head as to why so few were sent to firms. "Our analyst team talked to both managers and staff alike within the device center, within ORA, and we could not identify a single factor or event to attribute the drop to," FDA compliance office official Sean Boyd said in an interview. Also: US inspections are down 2%, while foreign audits are up 16%; the top three quality system violations are revealed by FDA; an update on the number of close-out letters sent to firms; and more.
This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fifth installment, former FDA investigations branch director Ricki Chase highlights the agency's top 5 inspection observations found on FDA-483 inspection forms, including failing to have procedures for corrective and preventive action (CAPA), complaint handling, purchasing controls, process validation, and nonconforming product.