How FDA Will Use Its New Authority against Denying, Limiting or Refusing Inspections – And Why Industry is Still Worried
This article was originally published in The Gold Sheet
How will FDA use its recently drafted guidance against obstructing inspections? Industry fears it may depend on how individual investigators interpret terms like “reasonable.”
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It turns out there’s a price to pay for removing computers and chromatography instruments so their data can’t be inspected.
Agency may share outcomes of remote record reviews in lieu of inspections at US and foreign facilities.
With inspectorate grounded by COVID-19, agency cannot clear remediated facilities or approve related applications – unless industry has a better idea.