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 FDA issued a draft Guidance last week, titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,” that explicitly gives investigators the right to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. continue to read here |
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Friday, July 19, 2013
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/07/put-down-that-camera-no-more.html
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