Warning letters, 483s, Recalls, Import Alerts, Audit observations
Amidst the heightened surveillance and enforcement actions initiated by different state licensing authorities (state FDAs)
The USFDA has released a new draft guidance, Container Closure Systems for Human Drugs and
Qvents provides useful tools for QMS processes – Risk Assessments, Continuous Process Validations, Supply Chain Traceability
The USFDA has issued a draft guidance for Establishing Impurity Specifications for Antibiotics in April
The USFDA has released a draft guidance titled “Responding to FDA Form 483 Observations at
Imprimis NJOF recalled three intraocular ophthalmic injection drug products in December 2025 (as per USFDA
Qvents Apps & ToolsNitrosamine and NDSRI Risk Assessment Tools – APIs, Drug Products, Excipients, Water
As per EUGMP requirements, EudraLex, Annex 16: Certification by a Qualified Person and Batch Release,
Author: Venkiteswaran.T.K The USFDA’s 2011 guidance on process validation advocates a life cycle approach and
Qvents Apps & Tools Access the Excipient Risk Assessment Tool – Click Here According to
