Friday, July 19, 2013

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/07/put-down-that-camera-no-more.html



Posted: 18 Jul 2013 08:32 PM PDT
By Doug Farquhar –
For decades (although not quite since the invention of film), the debate has raged among lawyers who advise clients about FDA inspections: can regulated industry insist that FDA investigators conducting inspections without a warrant put away their cameras, when the investigators try to take photographs in a facility?  FDA issued a draft Guidance last week, titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,” that explicitly gives investigators the right to take pictures, although FDA may be stretching its inspectional authority beyond what is required under the relevant statute.
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