FDA deficiencies [GxP / QC / QA]

posted by Helmut Homepage – Vienna, Austria, 2018-06-20 13:45 (1094 d 15:13 ago) – Posting: # 18930
Views: 3,186

Dear all,

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

[image]      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 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
21,529 posts in 4,499 threads, 1,523 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time: Saturday 04:59 CEST (Europe/Vienna)

Anyone who has never made a mistake
has never tried anything new.    Albert Einstein

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5