Inspections in the Age of FSMA: What to Do if the Government Shows Up at Your Door

November 14, 2017 2:00pm

Timothy G. Dietrich, Esquire
Barley Snyder, LLP (Reading, PA)

  • Examining new inspection mandates under FSMA
  • Defining the jurisdiction and authority of each agency to conduct inspections – FDA, USDA – FSIS, Department of Public Health
  • Assessing how these agencies work together in the context on an inspection
  • Knowing what the Government will be looking for during an inspection
  • Distinguishing a valid investigation from a fishing expedition and how your staff should react to each
  • Evaluating what has been seen over the last year during the initial implementation
  • Discussing the impact of the change to topic area specialized inspectors
  • 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