Analysis of FDA 483s Issued to Excipient Manufacturers Since 2000

By Jerry Chapman

This report looks across all excipient manufacturer 483s, including the one to DuPont that Redica Systems has in our Platform, and reviews the recurring concerns found by FDA in the last 20+ years.

Other areas examined in the report are:

  • An in-depth view of why DuPont Nutrition was inspected
  • Implications of the warning letter
  • 483 Observation Analysis using Redica Systems data