Tag: Yvins Dezan

USFDA 483 to Torrent Pharma cites defici

Torrent’s Chhatral, Gujarat facility (FEI: 3012740315) was inspected by USFDA (Investigator Yvins Dezan) in Dec

Lupin USFDA 483 cites deficient failure

USFDA 483 to Lupin Pithampur in Mar 2023 (Inspectors Eileen A Liu, Yvins Dezan) cites

Lupin USFDA 483 cites lapses in OOS inve

USFDA 483 to Lupin Pithampur in Mar 2023 (Inspectors Eileen A Liu, Yvins Dezan) cites deficiencies

USFDA 483 to Jubilant cites poor OOS Inv

USFDA483 for Jubilant Roorkee cited deficient review of unexplained discrepancies, OOS (out of specifications),  deficient CAPAs. Jubilant Generics

Jubilant USFDA 483 cites poor Chromatogr

USFDA 483 to Jubilant Roorkee cited inadequate review of unexplained discrepancies, aborting dissolution testing analysis for

Jubilant USFDA 483 – Lapses QC equipme

USFDA 483 for Jubilant Roorke cited inadequacies in investigation of equipment breakdowns, error messages, alarms.

Lack of Training and Awareness Across Ma

USFDA 483 to Lupin Pithampur unit cite Inadequacy of training and awareness across the management