What Not To Do When An FDA Inspector Knocks At Your Door
This article was originally published in The Rose Sheet
Executive Summary
FDA tweaks its guidance on what constitutes interference with facility inspections to include examples of “reasonable” explanations for delays, without addressing many industry concerns raised during a comment period. Created to provide FDA’s perspective on 2012 changes to federal food and drug law related to adulterated drug products, the guidance’s “sweeping” language suggests it could have relevance for inspections of cosmetic facilities conducted by the agency, attorneys say.
You may also be interested in...
FDA Warning Letter Renews Concerns About Barring Inspection Photos
An FDA warning letter issued in August to OTC drug manufacturer Homeolab has revived discussion about companies' options when it comes to investigator photographs during facility inspections, prompting fresh insight from industry attorneys on the issue's legal underpinning and existing case law.
Rx Companies Push For Exemptions To Breadth Of FDA Inspections
Sterile areas, cell therapies, and security systems are just a few of the items where industry wants FDA inspector access limited without triggering a new law that would make products in a facility deemed adulterated.
Divided US FDA AdComm Backs Molnupiravir Authorization But Wants More Studies
In 13-10 vote, panel finds reduction in COVID-19 hospitalizations and deaths outweighs risks. Four members say FDA should reconsider authorization if a more effective and safer therapy comes along. They concur molnupiravir should not be recommended for use in pregnancy but available to those who want it.