RAPS

Obstructing Facility Inspections Can Result in Drugs Being Found Adulterated, FDA Guidance Says

The US Food and Drug Administration (FDA) is out with a new draft guidance for industry establishing a framework by which a pharmaceutical manufacturer may delay, deny, limit or refuse an inspection ...
JD Supra

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. 1 This announcement applies to ...
RAPS

FDA Finalizes Policy to Cut Down on Suspicious Behavior During Facility Inspections

The US Food and Drug Administration (FDA) has put the finishing touches on a new policy intended to ensure the companies it regulates aren't able to hide problems from it during the course of ...