Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Recall / Event ID:90634 / Recall Number:

Strides in July 2022 recalled from US market 1032 bottles of Prednisolone USP 20mg tablets for

Warning letter / Mylan / MARCS-CMS 60750

USFDA Warning letter to Mylan in 2020 cited inadequacy of cleaning, cleaning procedures, risk assessment of

Warning letter /Mylan / MARCS-CMS 607508

USFDA Warning letter to Mylan in 2020 cited inadequate procedures to monitor and control recovered

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