Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

CDSCO Directs Pharma Solvent Manufacture

Indian drug regulator, Central Drugs Standard Control Organisation (CDSCO) has issued new directions for stringent

USFDA Updates Consideration for CES for

The USFDA has published a draft guidance updating scientific considerations for the use of comparative

FDA Classifies Novo Nordisk Plant OAI, P

Novo Nordisk’s Bloomington plant (FEI 3005949964, Catalent Indiana LLC) is classified OAI by USFDA in

Hetero Warehouse Flagged for Serious Lap

FDA conducted an inspection at the Hetero Labs Ltd, Warehouse at Nakkapally Village, Vishakapatnam, Andra

Malta Medicines Authority Maintains cGMP

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

Another Cough Syrup Fiasco

Reports of child deaths linked to contaminated cough syrups are once again creating panic in

FDA Announces Measures to Speed Up Revie

Amid all the ongoing Tariff Turf War, the U.S. Food and Drug Administration (FDA) has

Janssen Vaccine Unit Warning Letter Flag

Janssen Vaccines Corp., a Johnson & Johnson company operating in Korea, was issued an FDA

USP Launches Whatsapp Channel

USP has launched a WhatsApp channel. Through the channel, followers will receive updates in USP

OAI Classification for Sun Pharma Halol

In September 2025, the USFDA classified Sun Pharmaceutical Industries Ltd.’s Halol facility as OAI (Official