FDA Inspections & International Authority Audits

FDA Inspections

 FDA Inspections and Audits from other International Authorities as well as Certification Audits by Notified Bodies are becoming increasingly challenging for many companies. We support our clients to prepare and manage inspections and audits.

 

Inspection/Audit preparation

  • Mock Audit with former FDA inspector
  • Targeted deep dive assessments
  • Inspection readiness Program
  • Risk mitigation program
  • Training of key personnel
  • Organizational inspection set up including. front and back office
  • Professional interpreter
  • Compliance / remediation program
  • Communication with authorities
  • 483 and Warning Letter response

 

FDA Inspections

WP-Backgrounds Lite by InoPlugs Web Design and Juwelier Schönmann 1010 Wien