Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA Warning letter to Glenmark Cites C

Warning letter / Glenmark, Goa, India /FEI 3004672766 / MARCS-CMS 637314/ 320-23-04/ NOVEMBER 22, 2022/

Qvents
April 18, 2023

Cross Contamination Concerns: FDA Warnin

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

Qvents
April 17, 2023

USFDA Warning letter to Mylan on Handlin

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