Warning letters, 483s, Recalls, Import Alerts, Audit observations
In March 2025, Glenmark initiated recall of 23 products (148 lots) in US for cGMP
Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with
Janssen’s Korean Vaccine unit Janssen Vaccines Corporation (FEI 3012637764) received an USFDA 483 for critical
Authored by: Venkiteswaran.T.K, SubrangshuChourdhary, Srinivas Churya, Satish Reddy, Sanjeev Kumar Singh Aarti Drugs API facility in Tarapur, India
Authored by: Venkiteswaran.T.K, Subrangshu Chourdhary, Srinivas Churya Jubilant Generics Roorkee facility was inspected in January
USFDA inspected Granules India’s Finished Dosage and PFI facility (FEI 3004097901) at Gagillapur Village, Hyderabad
FDA has published the USFDA Form 483 issued to Novo Nordisk API manufacturing facility at
Five different facilities of Eugia across India and US were inspected by USFDA between December
With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary The USFDA inspection
With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary, Veena Raj The USFDA Form
