CAPA: Key Stumbling Block for Device Firms

Inspection Trends Show CAPA-Related Problems Common Among Medical Device Firms

GE OEC Medical Systems recently signed a consent decree with the FDA because of CGMP deficiencies, including failure to establish and maintain adequate corrective and preventive action procedures. The news that a company this size has a broken CAPA system is shocking. But at the same time, it is not altogether unexpected if you consider inspection trends for this industry.

Twenty-one percent of all observations noted during FDA inspection of medical device firms in fiscal year 2005 were related to CAPA.  Based on subsystems provided under QSIT (Quality System Inspection Technique), CAPA was also the top reason for medical device firms receiving Form 483 citations in the same year. Records/documents/change control and management subsystems were tied for Number Two. When it comes to Warning Letters, 17 percent sent to medical device companies in 2005 involved problems with CAPA.

The trends were presented by Timothy Ulatowski, director of Office of Compliance of the FDA’s Center for Devices and Radiological Health (CDRH), at a workshop co-sponsored by the agency and Advanced Medical Technology Association last year.

Ulatowski reiterated the premise of Quality System Regulation (QSR), which was meant to ensure that finished devices are safe, effective, and in compliance.  He presented a list of 17 citations in Warning Letters issued by the FDA to medical device firms in 2005. Based on the number of letters evaluated, the citations were ranked as follows:

  1. CAPA (21 CFR Part 820.100), 17%
  2. Complaint files (21 CFR Part 820.198), 14%
  3. Management responsibility (21 CFR 820.20), 13%
  4. Acceptance activities (21 CFR 820.80, 820.86), 11%
  5. Process validation (21 CFR 820.75), 9%
  6. Design controls (21 CFR 820.30), 8%
  7. Production and process controls (21 CFR 820.70), 7%
  8. Records management (21 CFR 820.180, 820.184), 7%
  9. Purchasing controls (21 CFR 820.50), 7%
  10. Nonconforming products (21 CFR 820.90), 6%
  11. General provisions for medical device reporting (21 CFR 803.17, 803.18), 5%
  12. Document controls (21 CFR 820.40), 5%
  13. Manufacturer reporting requirements for medical device reporting (21 CFR 803.50, 803.52), 5%
  14. Personnel (21 CFR 820.25), 5%
  15. Inspection, measuring, and equipment (21 CFR 820. 72), 3%
  16. Labeling and packaging control (21 CFR 820.120, 820.130), 2%
  17. Handling storage, distribution, and installation procedures (21 CFR 820.140, 820.150, 820.160), 1%

Read more about CAPA:


FDA Links

  • QSIT

  • GE OEC Medical Systems Signs Consent Decree with FDALink

Link to Timothy Ulatowski’s Presentation:

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