Navigating FDA's Non-Inspection Enforcement Actions

Redica Systems and others have published lots of tips on navigating inspection-based FDA enforcement actions for life sciences companies. But what about non-inspection enforcement actions? This presentation covers the reasons for FDA initiating warning letters and actions, consequences of misbranding for companies, and the importance of responding to warning letters and product recalls. It also emphasizes the significance of consent decrees as a control tool for the FDA and provides follow-up details for further inquiries.

FDA actions not originating from inspections - other reasons why FDA may initiate Warning Letters and Actions:
- Voluntary Records Requests,
- Unapproved Drugs & Devices,
- Advertising & Promotion,
- OTC drugs by monograph, import-export violations (customs referrals),
- Improper distributions