May 23, 2011

The US FDA’s Center for Devices and Radiological Health has released data on warning letter cites regarding manufacturers’ quality system deficiencies in 2010.

The CDRH sent out 89 warning letters containing 577 cites in total last year, primarily pertaining to corrective and preventative actions (CAPAs) and production and process controls (P&PC), which respectively accounted for 186 and 168 cites.

In terms of CAPA subsystem deficiencies cited by the regulator, 21 CFR 820.100 (Subpart J of the Quality System Regulation) caused the most problems, apparently, warranting 83 warnings from the CDRH. Another 78 cites were caused by 21 CFR 820.198 (complaint files), followed distantly by 21 CFR 820.90 (nonconforming product), for which the regulator cited 25 deficiencies.

In the P&PC category, the CDRH cited 35 deficiencies for 21 CFR 820.70 (production and process controls), as well as 34 deficiencies apiece for 21 CFR 820.75 (process validation) and 21 CFR 820.80 (receiving, in-process and finished device acceptance).

The new CRDH figures clearly point out which quality system compliance areas are creating the biggest challenges for manufacturers, as CAPA and P&PC deficiencies significantly outnumbered design, management and document control cites. 


  • Stewart Eisenhart