Discussion forum for Pharma Quality events, Regulatory Actions

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

Malta Medicines Authority Maintains cGMP

Pune based Akriti Pharmaceuticals Private Limited’s EUGMP Certificate remains suspended as the facility remains in

Qvents
October 22, 2025

USFDA 483 to Novo Nordisk Cite Lapses in

FDA has published the USFDA Form 483 issued to Novo Nordisk API manufacturing facility at

Qvents
October 30, 2024

USFDA 483 / Intas / May 2023 /Manipulati

USFDA483 to Intas cites manipulated visual inspection reports; failure to characterise particles observed in injection

Qvents
July 24, 2023