Regulatory Horizons: FDA’s Current Inspection Focus: What Companies Are Really Getting Cited For

In this episode of Regulatory Horizons, Winston Kirton breaks down the recurring issues driving FDA Form 483s and warning letters, from data integrity and quality oversight to supplier controls and documentation gaps.

If your compliance program looks solid on paper but cracks appear under scrutiny, FDA will find them. Tune in for a clear look at what today’s inspections are really testing—and how companies can stay ahead.

Questions and comments: wkirton@bakerlaw.com