Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

FDA Issues guidance for Handling and Ret

FDA has issued a new guidance for handling reserve samples from bioavailability (BA) and bioequivalence

Qvents
March 29, 2024

FDA concern on Accord Healthcare Tacroli

FDA has raised concerns about therapeutic equivalence of Tacrolimus capsules of Accord Healthcare to brand

Qvents
September 20, 2023