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RegisterFDA deficiencies [GxP / QC / QA]
posted by Helmut 
– Vienna, Austria, 2018-06-20 15:45 (2127 d 01:36 ago) – Posting: # 18930
Views: 4,351
Dear all,
I suffered from a masochistic fit and explored the FDA’s Clinical Investigator Inspection List. Below the two main deficiencies.
![[image]](img/uploaded/image521.png)
Number of inspections and findings decreasing. Lean government?
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!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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 [GxP / QC / QA]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- File update ? Helmut 2018-06-20 15:50
Ing. Helmut Schütz