How to Navigate FDA’s Non-Inspection Enforcement Actions

Presented Tuesday, April 30, 2024

This webinar focused on the concept of FDA actions not originating from inspections but the other reasons why the FDA may initiate Warning Letters and Actions. Most notably, we discussed Voluntary Records Requests, Unapproved Drugs, and devices, Advertising and promotion, OTC Drugs by monograph, import-export violations (customs referrals), improper distributions, etc.

FDA may use evidence of these violations to bring enforcement actions against companies. A company must understand the regulation and the law behind it, know its rights, know when to call legal counsel, and have a detailed plan to avoid and deal with these alleged violations when they occur.