File update ? [GxP / QC / QA]

posted by Ohlbe – France, 2018-06-20 14:49 (949 d 11:52 ago) – Posting: # 18932
Views: 2,459

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

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