Warning letters, 483s, Recalls, Import Alerts, Audit observations
Sagent is recalling two lots of Docetaxel injection in US. The recall follows a customer
Sun Pharma Dadra unit was inspected by USFDA in December 2023 by FDA investigator Pratik
USFDA inspection of Cipla, Patalganga site manufacturing APIs and Tablets resulted in USFDA 483 with
Chinese API Manufacturer Sichuan Deebio Pharmaceuticals was awarded USFDA 483 with six observations citing Data
Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators
Laurus, Visakh (India) was issued USFDA 483 with five (5) observations following USFDA inspection by
Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators
Dr.Reddy’s Laboraties (DRL) site was inspected by USFDA (Investigators Saleem A Akhtar & Pratik S
The DRL site was inspected by USFDA (Investigators Saleem A Akhtar & Pratik S Upadhyay)
Natco Pharma (india) Kothur facility was inspected by USFDA (Investigators Pratik S. Upadhyay and Saleem
