Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Janssen Vaccine Unit Warning Letter Flag

Janssen Vaccines Corp., a Johnson & Johnson company operating in Korea, was issued an FDA

Metallic Particles in APIs, Complaint In

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

Amneal Warning Letter Cites Fibers in PP

The USFDA issued a Warning letter to Amneal Pharmaceuticals following critical deviations observed during an

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 issued a Warning letter to Glenmark Facility at Pithampur (FEI 3008565058) in July 2025.

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