Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Warning letter / Centrient India / MARCS

USFDA Warning letter to Centrient India (Toansa, Punjab FEI 3004497364) in December 2022 cited inadequate

Warning letter / Centrient India / MARCS

USFDA Warning letter  to Centrient India (Toansa, Punjab FEI 3004497364) in December 2022 cited deficiencies in investigating

Warning letter / Glenmark, Goa, India /F

USFDA issued Warning letter to Glenmark, Goa, India facility (FEI 3004672766), cites lapses in procedure

Cross Contamination Concerns: FDA Warnin

In September 2022, USFDA issued a Warning letter to Lupin API facility at Tarapur, India

USFDA Warning letter to Mylan on Handlin

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