File update ? [GxP / QC / QA]
Dear Helmut,
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 ?).
Plus the shutdown ?

❝ 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 ?

—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- FDA deficiencies Helmut 2018-06-20 13:45 [GxP / QC / QA]
- 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