FDAnews
www.fdanews.com/articles/159646-drugmakers-question-fda-thinking-on-new-inspection-powers

Drugmakers Question FDA Thinking on New Inspection Powers

October 7, 2013
The FDA’s interpretation of what constitutes delaying or denying an inspection is far too subjective, and highlights the need for an appeals process for pharma companies flagged as obstructionist, drugmakers say in comments. Violations outlined in recently published draft guidance on the issue could be interpreted differently from investigator to investigator, they said.
Drug Industry Daily