Warning letters, 483s, Recalls, Import Alerts, Audit observations
The guidance provides information on how FDA decides goal dates for a drug application (ANDA,
Eugia US LLC is recalling two more injectable products in US for failed impurities, degradation
The scientific community mourns the loss of Dr.Akiro Endo, whose death was announced by the
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
