RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > Compliance Advice: Dispelling Myths of Corrective Action Systems

Compliance Advice: Dispelling Myths of Corrective Action Systems

Posted 01 July 2008 | By

I am confused about the results of an FDA inspection of our medical device facility. The investigator issued an FDA Form 483 citing our approach to corrective and preventive actions (CAPA). We have not established a formal CAPA program because we are a small company, but I believe we address all CAPA requirements.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe

Regulatory Focus™ is doing essential, non-biased journalism during this unprecedented time. We appreciate your support as we bring you the news and intelligence you need to make an impact on global healthcare.

Regulatory Focus™ provides the intelligence you need to impact global healthcare during this crisis. Thank you for your support.