FDA inspections

Inspections from regulatory bodies can be very challenging, especially those made by the FDA.

We can help you with:

  • Assessing of your quality management system compliance to QSR (21 C.F.R. 820), identifying vulnerable regulatory areas
  • The communication with the FDA, for example replying to Form 483 non-conformances, warning letters, etc.
  • FDA inspection preparation, for example mock audits, PMA Preapproval inspections
  • Support you during inspections, front office or back office, depending on your needs

Contact me for further information
Nils-Åke Lindberg
Office +46 8 621 01 05 or send me an e-mail