Discussion forum for Pharma Quality events, Regulatory Actions

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

FDA Warning letter to Dupont cites Inade

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

Qvents
April 18, 2023

IPEC issues Questionnaire for Excipient

IPEC Federation announced the availability of the “Questionnaire for Excipient Nitrosamines Risk Evaluation” (version 1,

Qvents
February 27, 2023

USFDA 483 Flags Dupont for Lapses in Avi

USFDA issues Warning letter to DuPont Nutrition USA Inc., Newark, Delaware facility (FEI 3013947845) for

Qvents Team
January 23, 2023