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

 
• By Brian Bossetta

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 In a previous draft guidance, the agency expanded its longstanding policy on inspections of drug companies to include device makers as well.

Entry Denied
• Source: Shutterstock

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 drug manufacturers to include that of device firms as well. The agency based its 2022 draft on a 2014 document specific to drug companies

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More from Policy & Regulation

Cosmetics Consortium Shares Studies With FDA To Build Confidence In Animal Testing Alternatives

 
• By Lauren Nardella

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Little Industry Opposition To FDA Plan To Remove Synthetic Dyes, Or Agreement They’re Unsafe

 
• By Malcolm Spicer

Dyes and colors which FDA says industries agree should no longer be used aren’t unsafe and are currently used only with the agency’s approval, industry stakeholders say. Center for Science in the Public Interest says the dyes are used “in tens of thousands of foods and beverages that are commonly consumed here in the United States.”