Discussion forum for Pharma Quality events, Regulatory Actions

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

Warning letter / Glenmark, Goa, India /F

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

Qvents
April 18, 2023

Warning letter / Lupin / MARCS-CMS 63370

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

Qvents
April 17, 2023

Warning letter / Mylan / MARCS-CMS 60750

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

Qvents
April 17, 2023

Warning letter /Mylan / MARCS-CMS 607508

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

Qvents
April 14, 2023