Bioequivalence and Bioavailability Forum

FDA deficiencies [GxP / QC / QA]

posted by Helmut  – Vienna, Austria, 2018-06-20 15:45 (2366 d 23:56 ago) – Posting: # 18930
Views: 4,959

Dear all,

I suffered from a masochistic fit and explored the FDA’s Clinical Investigator Inspection List. Below the two main deficiencies.

      Number of    Failure to follow     Inadequate and
Year  inspections  investigational plan  inaccurate records
2008      620          152 (24.5%)           92 (14.8%)
2009      587          150 (25.6%)           98 (16.7%)
2010      507          121 (23.9%)           84 (16.6%)
2011      381           91 (23.9%)           67 (17.6%)
2012      501          120 (24.0%)           76 (15.2%)
2013      423           96 (22.7%)           55 (13.0%)
2014      543          124 (22.8%)           78 (14.4%)
2015      582          159 (27.3%)           69 (11.9%)
2016      401           86 (21.4%)           37 ( 9.2%)
2017      269           43 (16.0%)           23 ( 8.6%)

Number of inspections and findings decreasing. Lean government?

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• FDA deficienciesHelmut 2018-06-20 13:45 [GxP / QC / QA] 
  • FDA deficiencies nobody 2018-06-20 14:09
  • File update ? Ohlbe 2018-06-20 14:49
    • File update ? Helmut 2018-06-20 15:50
      • File update ? ElMaestro 2018-06-20 15:59