Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
The USFDA 483 issued to Sun Pharma, Dadra unit in India (FEI 3004561553) published by
J&Js paediatric cough syrup Benylin is being recalled in several African countries following detection of
The revised EDQM guideline “Content of the dossier for chemical purity and microbiological quality of
