Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

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

FDA has published the Warning Letter issued to the Viatris Pithampur facility in December 2024. This Warning

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

Deficiencies That Lead to Officiation Ac

Five different facilities of Eugia across India and US were inspected by USFDA between December

USFDA Issues Warning Letter to Zydus: Fl

Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,

Chine API Manufacturer Chengdu KeCheng I

The USFDA issued a Warning Letter to the Chinese API manufacturer Chengdu KeCheng Fine Chemicals