Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Metallic Particles in APIs, Complaint In

The USFDA issued a Warning letter to Hikal’s API facility in Jigani, Bangalore, India. The

Shiva Analytical Warning Letter: Data In

The USFDA has issued a Warning Letter to Shiva Analyticals’ Bangalore facility following significant cGMP

Glenmark Warning Letter Cites 21 CFR 211

USFDA Warning letter to Glenmark Facility at Pithampur (FEI 3008565058), cited cGMP violations at multiple

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

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

Deficiencies That Lead to Officiation Ac

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

Warning letter Sun Pharma Dadra Unit: In

Sun Pharma’s Dadra Unit was issued FDA Warning letter in June 2024, following critical observations

Inadequacy of Investigations, Root cause

Laurus Synthesis was issued an Untitled Letter by USFDA in May 2024, following critical observations

Chine API Manufacturer Chengdu KeCheng I

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