Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Document Control Deficiencies – US

USFDA 483 to UCB Belgium cites fundamental gaps in document control  – uncontrolled forms for

Intas USFDA 483 cites Data Integrity, to

USFDA Inspection of Intas, Matoda, Sanand facility in India (FEI 3004011473); from 22 November 2022 to

Centrient India Warning letter Cites Lap

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

USFDA 483 Flags Dupont for Lapses in Avi

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