Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Intas Recall Cisplatin Injection For Imp

Accord Healthcare Inc, US is recalling one lot of Cisplatin injection due to failed impurities.

FDA approves Roche’s Inavolisib fo

USFDA has approved Inavolisib ((Itovebi) of Genentech in combination with palbociclib and fulvestrant, for the

EMA To Review Finasteride and Dutasterid

The European Medicines Agency (EMA) has initiated a review of finasteride and dutasteride due to

Spurious Drugs Linked to Sun Pharma, Gle

CDSCO has published an update on the Spurious and Misbranded drugs in September 2024. Medicinal

CDSCO Drug Alert for August 24

CDSCO has published alert of list of drugs Not of Standard Quality (NSQ) identified during

FDA Updates Guideline for Control of Nit

FDA has issued an Updated Guidance for Control of Nitrosamines in Human Drugs in September

USFDA Issues Warning Letter to Zydus: Fl

Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,

Ocaliva: EC Withdrawal of Approval Tempo

The European Commission (EC) revoked the conditional marketing authorization (CMA) of Advanz Pharma’s Ocaliva (obeticholic

CDSCO Alert: Baxter Recalls Fibrin Seala

CDSCO has published a drug alert regarding voluntary recall of Tisseel Lyo Fibrin Sealant VHS/D

CDSCO NSQ Drug list: Failure for Dissolu

CDSCO has published the NSQ (Not of Standard Quality) alert for July 2024. The list