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:
- On CAPA system deficiencies
- On right to review all CAPAs even when companies begin them as a result of internal audits
Why CAPA
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.
SOLUTION
Effective CAPA systems reduce regulatory risk by managing and streamlining the quality-reporting process.
Advantage:
- Reduces bad inventory
- Generates fewer regulatory warnings and recalls, and
- Increasing company profits and customer satisfaction
