Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

FDA Issues Warning Letter to Aspen Bioph

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

FDA Issues Repeat Warning Letter to Thai

The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP

Contamination Control and Data Integrity

Granules India received a warning letter from the USFDA in February 2025. This was along

Facility Registration Violations, Refusa

Indian API manufacturer Jagsonpal Pharmaceuticals was issued a Warning Letter by the US FDA in

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

Sanofi’s API Facility in US Issued

The USFDA issued a warning letter in January 2025 to Sanofi’s API facility in Framingham,

FDA Warning Letter to Viatris: Concerns

Authored by: Venkiteswaran.T.K, Srinivas Churya FDA has published the Warning Letter issued to the Viatris Pithampur facility in December

USFDA Flags Major cGMP Deviations at Une

New Delhi based Unexo Life Sciences has initiated a major recall of several medicated patch

Delaying, Denying, Limiting, Refusing In

Chinese OTC Manufacturer Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd was inspected by USFDA in March