The FDA Enforcement Manual is the comprehensive online resource guide to the Food and Drug Administration’s enforcement authority, policies and practices for the drug, medical device, biologics, food, cosmetics and tobacco industries. The manual will help you manage potentially expensive and time-consuming FDA enforcement activity by outlining the enforcement process; explaining the powers that the agency has during the process as well as the rights of companies and individuals targeted for enforcement action, and offering practical expert help on how to deal with FDA personnel and procedures.
Content
- Tab 100 - Overview of FDA Enforcement
- Tab 200 - FDA’s Enforcement Organization: Who Does What
- Tab 300 - Inspections
- Tab 400 - Warning Letters
- Tab 500 - Adverse Publicity Disseminated by FDA
- Tab 600 - Recalls and Administrative Injunction
- Tab 700 - Product Approvals
- Tab 800 - Government Contracts
- Tab 900 - Imports
- Tab 1000 - Civil Money Penalties
- Tab 1100 - Seizures
- Tab 1200 - Injunctions
- Tab 1300 - Criminal Liability
- Tab 1400 - Criminal Case Development
- Tab 1500 - Sentencing
- Tab 1600 - Current Good Manufacturing Practices
