readiness. Throughout the pandemic, the lack of FDA inspections has created new challenges and heightened existing problems, largely due to delays in upgrading legacy facilities. Since the ...

Typically, FDA inspections can be highly structured and there are procedures that are to be followed as you prepare for state of readiness. It is important for anyone who might be involved in the ...

Conduct mock audits to simulate FDA inspections and evaluate readiness. Prepare teams to answer audit queries confidently and provide evidence promptly. If required, address audit findings ...

In a letter to FDA Deputy Commissioner for Human Foods ... wrote that shifting funds away from the Office of Inspections and Investigation would slash resources available to state and local ...