Helmut
★★★
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Vienna, Austria,
2018-06-20 13:45
(893 d 10:22 ago)

Posting: # 18930
Views: 2,912
 

 FDA deficiencies [GxP / QC / QA]

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
nobody
nothing

2018-06-20 14:09
(893 d 09:58 ago)

@ Helmut
Posting: # 18931
Views: 2,422
 

 FDA deficiencies

Nope, world is getting better day by day by day....

Tomorrow you can buy condos in North Korea. Think positive!

Kindest regards, nobody
Ohlbe
★★★

France,
2018-06-20 14:49
(893 d 09:18 ago)

@ Helmut
Posting: # 18932
Views: 2,415
 

 File update ?

Dear Helmut,

» Number of inspections and findings decreasing.

Last update of the list: 19 March 2018. All inspections in the list have a NAI/VAI/OAI classification. It looks like they only put the inspections on the list once the classification is assigned, which is after the Center reviews the field report... which of course only happens after the FDA investigator writes the report. Let's wait for the next update: we may well see an increase in the number of 2017 inspections (possibly even of 2016 ?).

» Lean government?

Plus the shutdown ?
:-D

Regards
Ohlbe
Helmut
★★★
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Homepage
Vienna, Austria,
2018-06-20 15:50
(893 d 08:17 ago)

@ Ohlbe
Posting: # 18933
Views: 2,420
 

 File update ?

Dear Ohlbe,

» All inspections in the list have a NAI/VAI/OAI classification. […] Let's wait for the next update: we may well see an increase in the number of 2017 inspections (possibly even of 2016 ?).

THX for the clarification!

» » Lean government?
» Plus the shutdown ?
» :-D

Was just a couple of days. ;-)

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Belgium?,
2018-06-20 15:59
(893 d 08:08 ago)

@ Helmut
Posting: # 18934
Views: 2,411
 

 File update ?

Hi Hötzi,

» » Plus the shutdown ?
» » :-D
»
» Was just a couple of days. ;-)

I think Ohlbe meant the meltdown?!?
Is going to be just 4-8 years.:-):-)

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.
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