Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
USFDA 483 / UCB Farchim SA/ June 2023 / Deficiencies in Method Transfer, Material receipt
Qvent post discusses the Regulatory guidances and Requirements for Electronic data controls and review, Data
