Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Warning letter / DuPont Nutrition USA In

USFDA Warning letter to Dupont cites inadequate change management program. The warning letter to Dupont Nutrition USA in

Warning letter / DuPont Nutrition USA In

USFDA Warning letter to Dupont, USA cites inadequate laboratory controls, integrity of data and quality system does

Concerns of Beta Lactam Contamination: U

Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER 07, 2022/ Observation 2 USFDA

Centrient India Warning letter Cites Lap

Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER 07, 2022/ Observation 1 USFDA

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