Legal Considerations | Interacting with the FDA Before, During, and After Inspections
Presented on Tuesday, May 23, 2023
- Neil DiSpirito, FDA law partner at Brown Rudnick
Download our webinar focusing on and discussing the legal concept of the FDA inspection as a Warrantless Search, removing the 4th and 5th Amendments’ due process clauses in gathering evidence of both an administrative and civil and criminal nature and your rights.
Evidence of these inspection-determined violations may be used to bring legal enforcement actions against the company. To avoid violations and potential enforcement actions, a business must know its rights and have a detailed plan and procedure for interacting with the FDA before, during, and after inspections. And when disagreements or allegations of noncompliance arise during the inspection or review process, having legal counsel readily available to respond and handle these inquiries or actions can be a game-changer and avoid a long regulatory enforcement policy and financial disaster.
If you have any questions or comments, please do not hesitate to contact someone on our team at [email protected].