Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site
Glenmark recalled several lots of Rizatriptan Benzoate Tablets and Rizatriptan Benzoate Orally Disintegrating Tablets in
Elanco Animal Health announced that the USFDA has completed its comprehensive, multi-year review of Bovaer
Dr.Reddy’s (DRL) is recalling 1176 bottles of Sirolimus 1mg tablets (NDC 55111-653-01) in US for
Everest Organics Ltd (Telangana, India) was issued a GMP Non-Compliance Report with recommendation to suspend
CDSCO has issued spurious drug alert for five medicinal products. The spurious drug alert includes
Aurobindo arm, Eugia Pharma Specialities facility at Bhiwadi, Rajasthan was issued USFDA 483 with seven
USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations.
The Drug Controller General of India (DCGI) has notified that effective from May 15, 2024, the issuance of
WHO has issued an alert on falsified Propylene glycol bearing name of Dow detected in
