Bioequivalence and Bioavailability Forum • FDA deficiencies

FDA deficiencies [GxP / QC / QA]

posted by Helmut – Vienna, Austria, 2018-06-20 15:45 (2130 d 03:25 ago) – Posting: # 18930
Views: 4,391

Dear all,

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

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      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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

FDA deficienciesHelmut 2018-06-20 13:45
- 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