Tag: USFDA 483

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.

Lapses in Process Validations: Torrent U

An USFDA 483 (2019) to Torrent cites deficient Process validation practices and procedures. The observations

Instrument Settings, Operator Training:

Following the USFDA inspection  during 8-16 April 2019 at Torrent, Indrad, India (FEI 3005029956) by

Deficient OOS Investigation and Handling

USFDA 483 Torrent Indrad facility in India (FEI 3005029956); inspection from 8 April 2019 to

Lack of Training and Awareness Across Ma

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

USFDA 483 Flags Dupont for Lapses in Avi

USFDA issues Warning letter to DuPont Nutrition USA Inc., Newark, Delaware facility (FEI 3013947845) for