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Foreign Facilities Get Details From US FDA On Avoiding ‘Refusal To Allow Inspection’ Violation

 
• By Malcolm Spicer

Guidance states regulatory violation of refusing to permit entry of FDA investigator to inspect or not permitting an inspection includes “statements, actions, and passive behaviors that prevent or delay us from scheduling or fully conducting an inspection.”

• Source: Shutterstock

“Passive behaviors” are among the actions by food and dietary supplement manufacturers outside the US that count as refusing to allow Food and Drug Administration officials to inspect their facilities and can lead to holds on imports of their products.

In a guidance published on 20 October, the FDA explains its thinking on when agency officials are unlawfully prevented from...

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Cloudy Tariff Conditions Expected To Linger In US

 
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More from Policy & Regulation

US FDA Extracts More Evidence To Ban Kratom

 
• By Malcolm Spicer

Recent warning letters to seven companies marketing products with kratom extract known as 7-OH are FDA’s first in three years referencing unlawful products containing kratom and the first of all its kratom-related warnings to reference extracts from the botanical.

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
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Cloudy Tariff Conditions Expected To Linger In US

 
• By Malcolm Spicer

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.