FDA Explains Reasons For Delaying, Limiting Or Refusing Inspections In Final Guidance

The US FDA has issued its final guidance defining manufacturer behaviors it deems as hampering the agency’s ability to conduct an inspection. In a previous draft guidance, the agency expanded its longstanding policy on inspections of drug companies to include device makers as well.

The Food and Drug Administration’s final guidance, “Circumstances that Constitute Delaying, Limiting, or Refusing a Drug Inspection,” describes manufacturer actions the agency views as “delaying, denying, or limiting inspection, or refusing to permit entry or inspection.”

The final document supersedes the draft document the agency issued in 2022 which expanded the FDA’s policy on inspections of...