Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA 483 (Aug 2021) & Warning lette

Aurobindo Unit 1 (FEI 3004021253) was inspected by USFDA investigator Rita K Kabaso from August

USFDA 483 (Aug 2021) & Warning lette

Aurobindo Unit 1 (FEI 3004021253) was inspected by USFDA investigator Rita K Kabaso from August

USFDA Warning letters, 483s, WHO Alerts

Potential contamination of drug products with Diethylene Glycol(DEG), Ethylene Glycol(EG) has severe consequences including fatality

Warning letter / Glenmark, Goa, India /F

USFDA Warning letter to Glenmark cites deficiencies in Out of specification (OOS) investigations, firms response to

Warning letter / DuPont Nutrition USA In

USFDA Warning letter to Dupont cites inadequate evaluation of complaints, even though the Firm received several

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

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