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 evaluation of complaints, even though the Firm received several

Warning letter / DuPont Nutrition USA In

USFDA Warning letter to Dupont cites inadequate OOS investigations, Root cause and CAPA, Impact  evaluation. The warning letter

Warning letter / DuPont Nutrition USA In

USFDA Warning letter to Dupont cites failure to ensure test methods are suitable, use of Non

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

Warning letter / Centrient India / MARCS

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

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

Warning letter / Lupin / MARCS-CMS 63370

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