Aurobindo Pharma Unit-9 || USFDA Form 483 Observations || November 2022 ||

[@playlistajsy4486]

Root cause for impunity of OOS is spec revision. Will tou please explain briefly.
Earliee time points also not meets the specification for that particular impurity.
Hence they may revise specification limit.

[@andychen4169]

hi Sir, Could you provide me the link to this Form 483, I can't find it on the USFDA website

[@PharmaPill]

Please find Link
www.fda.gov/media/163754/download

[@andychen4169]

@@PharmaPill thanks😁

[@vijaykota24]

USFDA found one thing will write as different

[@PharmaPill]

🙂

[@vammsiathava2885]

Worst observation in one of the good company....