Barbara W. Unger

President, Unger Consulting

Jerry Chapman

Senior GMP Quality Expert, Redica Systems

The FDA issued a first-of-its-kind warning letter to an excipient manufacturer. This likely opens the door to a wide-ranging set of firms that could be inspected and receive enforcement actions, with potentially severe consequences for those who purchase excipients from firms with quality failures. Download the full report to learn more.

As of January 30, 2023, this document now contains a color-coded warning letter label analysis, demonstrating how quality system labeling works in Redica Systems. It also includes an event chain, showing the chronology and interrelation of the critical events leading up to this unprecedented warning letter.