Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA Inspection of Pharmathen’s Rodopi facility in Greece (FEI 3009961173) resulted in issuance of Form
FDA has published the USFDA Form 483 issued to sterile drug manufacturing facility of Fareva
Qvents provides useful tools for QMS processes – Risk Assessments, Continuous Process Validations, Supply Chain Traceability
In September 2025, the USFDA classified Sun Pharmaceutical Industries Ltd.’s Halol facility as OAI (Official
Author: Venkiteswaran.T.K The USFDA’s 2011 guidance on process validation advocates a life cycle approach and
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
The USFDA issued a warning letter in January 2025 to Sanofi’s API facility in Framingham,
The FDA has issued new guidance on “Considerations for Complying With 21 CFR 211.110.” According
FDA has published the USFDA Form 483 issued to Novo Nordisk API manufacturing facility at
Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,
