Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Data Integrity issues, Delayed records:

USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site

Risk of Nitrosamines in Rizatriptan and

Glenmark recalled several lots of Rizatriptan Benzoate Tablets and Rizatriptan Benzoate Orally Disintegrating Tablets in

FDA clears Bovaer – Elanco’s Met

Elanco Animal Health announced that the USFDA has completed its comprehensive, multi-year review of Bovaer

Dr.Reddy’s recall Sirolimus tablets fo

Dr.Reddy’s (DRL) is recalling 1176 bottles of Sirolimus 1mg tablets (NDC 55111-653-01) in US for

Eudra GMDP lists Everest Organics and Ak

Everest Organics Ltd (Telangana, India) was issued a GMP Non-Compliance Report with recommendation to suspend

CDSCO Spurious Drug Alert for Instgra, T

CDSCO has issued spurious drug alert for five medicinal products. The spurious drug alert includes

Eugia USFDA 483 Cites Inadequate Contain

Aurobindo arm, Eugia Pharma Specialities facility at Bhiwadi, Rajasthan was issued USFDA 483 with seven

Zydus Vadodara USFDA 483 cites Contamina

USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations.

CDSCO to take Charge of Export NOCs for

The Drug Controller General of India (DCGI) has notified that effective from May 15, 2024, the issuance of

WHO Alert on Falsified Dow Propylene gly

WHO has issued an alert on falsified Propylene glycol bearing name of Dow detected in