Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
IPCA unit at Dhar, Madhya Pradesh, India USFDA 483 cites Invalidation of OOS with inconclusive
USFDA 483 to Intas cites lapses in investigation and review of failures and discrepancies in
USFDA483 to Intas cites manipulated visual inspection reports; failure to characterise particles observed in injection
USFDA Inspected IPCA (Ratlam, India) site in June 2023, Inspectors – Rajiv R Srivastava, Salim
