Warning letters, 483s, Recalls, Import Alerts, Audit observations
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 Inspected UCB Farchim site at Bulle, Switzerland (FEI 3005023799) in June / July 2023.
USFDA 483 / UCB Farchim SA/ June 2023 / Gaps in Data Integrity program, lack
IPCA unit at Dhar, Madhya Pradesh, India USFDA 483 cites Invalidation of OOS with inconclusive
