By Jim Dickinson
FDA conducted 3% fewer medical device quality system surveillance inspections last year than in 2012.
Just-released device inspection results show that the agency performed 2201 quality system inspections in 2013, 51 fewer than the 2252 conducted in 2012. This small decrease is likely attributable to an increase in foreign inspections (460 in 2013 versus 393 in 2013), which require more agency resources, according to FDA.
While the agency may have conducted fewer inspections, the number of overall inspectional observations increased by 17% last year. According to the inspection report, the most frequent observations found in 2013 included:
- Corrective and preventive action procedures (21 CFR 820.100(a)).
- Complaint files, specifically establishing and maintaining procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)).
- Quality audits to assure that the quality system is in compliance with the established quality system requirements and determine the effectiveness of the quality system (21 CFR 820.22).
Additionally, warning letters with quality system citations fell 12% last year—from 164 in 2012 to 144 in 2013. Corrective and preventive action citations were the most cited infraction in warning letters, the report says.
Jim Dickinson is MD+DI's contributing editor.
[image courtesy of DAVID CASTILLO DOMINICI/FREEDIGITALPHOTOS.NET]