Showing posts with label Denying. Show all posts
Showing posts with label Denying. Show all posts

Tuesday, July 16, 2013

Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection Dated July 12, 2013

Ed Silverman over at Pharmalot has a new blog entry today, July 16, 2013 entitled How To Avoid Making FDA Inspectors Suspicious Or Angry.  Mr. Silverman points out a number of things that are common sense when it comes to making an inspector suspicious or angry.  He also states that the FDA has a draft of guidance (here).  While this is only a draft at this stage, I feel certain there will be a final guidance at some point in the near future.  And beyond all of Mr. Silverman's common sense items, remember one must always comply with the law--including court orders, subpoeas, legal request for documents, etc.  Ignoring those types of things are sure to get you in trouble.  There are legal process and procedures to object to such things but you can't just ignore them.