FDA Inspection Preparedness: Understanding Your Obligations

May 24, 2017 2:45pm

Sarah Brew
Partner
Faegre Baker Daniels LLP

Adam M. Ekonomon
Vice President and Deputy General Counsel
The J.M. Smucker Company

Maile Gradison Hermida
Partner
Hogan Lovells US LLP

  • Devising an inspection preparedness plan to meet with new regulatory requirements under FSMA and other regulations
  • Knowing what the Government will be looking for during an inspection
  • Formulating a Form 483 response post-inspection
  • Understanding the Government’s recourse when a response is not received at the end of the 15-day response period