Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

MHRA on FDA Warning Letters

In a blog posted on 8 August 2025, MHRA’s Chris Jones (IAG Chair) and Himal Makwana

Glenmark Warning Letter Cites 21 CFR 211

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

Glenmark Pithampur Facility Issued USFDA

USFDA has issued a Warning letter to Glenmark Pharma’s Pithampur manufacturing facility (FEI 3008565058). The

Yiling Pharma Warning Letter: Equipment

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter in June 2025

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