Bioequivalence and Bioavailability Forum • FDA deficiencies

Helmut
★★★

Vienna, Austria,
2018-06-20 15:45
(2493 d 11:34 ago)

Posting: # 18930
Views: 5,312

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.

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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

nobody nothing 2018-06-20 16:09 (2493 d 11:11 ago) @ Helmut Posting: # 18931 Views: 4,198	FDA deficiencies Post reply
	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 16:49
(2493 d 10:30 ago)

@ Helmut
Posting: # 18932
Views: 4,273

File update ?

Post reply

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
★★★

Vienna, Austria,
2018-06-20 17:50
(2493 d 09:30 ago)

@ Ohlbe
Posting: # 18933
Views: 4,240

File update ?

Post reply

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 🖖🏼 Довге життя Україна!
Helmut Schütz

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

ElMaestro ★★★ Denmark, 2018-06-20 17:59 (2493 d 09:21 ago) @ Helmut Posting: # 18934 Views: 4,200	File update ? Post reply
	Hi Hötzi, ❝ ❝ Plus the shutdown ? ❝ ❝ ❝ ❝ Was just a couple of days. I think Ohlbe meant the meltdown?!? Is going to be just 4-8 years. — Pass or fail! ElMaestro