Warning letters, 483s, Recalls, Import Alerts, Audit observations
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,
USFDA 483 issued to Dr.Reddys (DRL) API unit in Pydibhimavaram, India cites failure to validate
An USFDA 483 (2019) to Torrent cites deficient Process validation practices and procedures. The observations
