Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

FDA Extends Nitrosamine Timelines

USFDA has allowed drug manufacturers additional time for submission of mitigation actions and required changes

USFDA Issues Final Guidance for PFC For

USFDA has issued the final guidance for Pre-Submission Facility Correspondence (PFC) for prioritised generic drug

Data Integrity Concerns: USFDA Issues No

The USFDA issued a notification on 22 May, 2025 on Data Integrity concerns on reliability

FDA Issues Warning Letter to Aspen Bioph

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs

FDA Approves Sanofi’s New Hemophilia 

The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment

USFDA Issues Warning Letter to Global Ca

Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in

FDA Issues Warning letter to Chinese API

FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing

FDA Issues New Guidance on 21 CFR 211.11

The FDA has issued new guidance on “Considerations for Complying With 21 CFR 211.110.” According

FDA Warning Letter to Indoco Remedies Fl

Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical

Oral Phenylephrine Not Effective: FDA Pr

USFDA is proposing to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) drug