Inspections: What to Do if the Government Shows Up at Your Door

July 18, 2024 9:15am

Timothy Dietrich
Partner
Barley Snyder LLP

  • Examining 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
    • how to prep your records and employees for an inspection
    • how to handle a “surprise” inspection
    • how to respond to agent’s requests on-site
    • distinguishing a valid investigation from a fishing expedition and how your staff should react to each
  • 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