It comes as no surprise that design controls (21 CFR 820.30), complaint records (21 CFR 820.198) and CAPA (21 CFR 820.100) were among the top three most cited Quality System Regulation violations in 2012, and the trends continued in 2013.
In the first six months ending in June, 2013, the FDA issued 84 Warning Letters to device manufacturers, citing 534 violations, up from 69 Warning Letters in the same period of 2012.
Design review (21 CFR 820.30(e)) citations increased from 5.4% citations in 2012 to 8.2% in the first six months ending in June, 2013. The FDA cited a lack of adequate design reviews and design review procedures in the top five Design controls citations in 2013.
Failure to establish and maintain adequate procedures for validating the device design (21 CFR 820.30(g)), including software validation and risk analysis was cited most in 28.8% of Design controls violations, up from 25.6% in 2012.
20.5% of the Design controls citations in Warning Letters in 2013 cite a failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation (21 CFR 820.30(g)), a 3.4% increase from 2012.