Inspections: What to Do if the Government Shows Up at Your Door
Justin J. Prochnow
Shareholder
Greenberg Traurig LLP
Emily Cowley Leongini
Partner
Arent Fox Schiff
- Examining inspection mandates under FSMA
- Defining the jurisdiction and authority of each agency to conduct inspections – FDA, USDA – FSIS, Department of Public Health; State inspections under contract with FDA
- Determining if state’s authority or FDA’s apply
- Assessing how these agencies work together in the context of 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
- Understanding the difference between a “for cause” inspection and a “routine” inspection
- Samples and records access; authority to take photographs
- Evaluating an FDA 483; preparing an effective response
- Understanding the Government’s recourse when a response is not received at the end of the 15-day response period or is deemed inadequate