Discussion forum for Pharma Quality events, Regulatory Actions

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

Lapses in Process Validations: Torrent U

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

Qvents
April 11, 2023

Invalidation of OOS Results and Retestin

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

Qvents
April 11, 2023

Instrument Settings, Operator Training:

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

Qvents
April 11, 2023

Deficient OOS Investigation and Handling

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

Qvents
April 10, 2023