Preparing the Facility for Inspection


How to Create an Inspection Response Team: The 8 Key Roles

Owners and others at the establishment are required to cooperate with investigators and refrain from doing anything to obstruct them while they carry out their functions. But investigators can't just do whatever they want. There are limits to their powers. Read More

How to Perform a Pre-Inspection Compliance Audit

The IOM instructs FDA investigators to focus on 5 things in carrying out a current Good Manufacturing Practices (cGMP) inspection. Read More

How to Create an FDA Inspection War Room

The key function of the war room is to process FDA investigators' requests effectively and efficiently while protecting the company's rights and interests during the inspection process. Read More