Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

USFDA 483 / Jubilant Roorkee / 300689598

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

USFDA 483 / Torrent, Indrad, India / FEI

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

USFDA 483 / Torrent, Indrad, India / FEI

Torrent Indrad, India (FEI 3005029956) was issued USFDA form 483 following inspections by USFDA inspectors Lata Mathew, Jogy

USFDA 483 / Torrent, Indrad, India / FEI

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

USFDA 483 / Torrent, Indrad, India / FEI

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