Inspections: Former Regulator Shares What to Do When FDA Comes Calling

What should a devicemaker do if a team of FDA inspectors knocks on the door for an announced audit but has no Notice of Inspection Form 482 in hand? Show them to a comfortable place to wait and offer coffee or water, but don’t let them start the audit until the form has been signed by every inspector present, said Steve Niedelman, lead quality systems and compliance consultant with the law firm King & Spalding and a former FDA compliance officer.
Devices & Diagnostics Letter