The FDA issued 74 good manufacturing practice (GMP)-related warning letters to device firms last year, 84 percent of which contained citations for Corrective Action Preventive Action (CAPA) system deficiencies.

FDA Focusing:

  1. On CAPA system deficiencies
  2. On right to review all CAPAs even when companies begin them as a result of internal audits


CAPA management is integral to meet the FDA’s expectations and its GMP regulations. More than just a regulatory requirement, effective CAPA management also is a good business practice that can reduce company liability and warranty claims and increase customer satisfaction.


Effective CAPA systems reduce regulatory risk by managing and streamlining the quality-reporting process.


  1. Reduces bad inventory
  2. Generates fewer regulatory warnings and recalls, and
  3. Increasing company profits and customer satisfaction

More here>>

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: