Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA has released a draft guidance titled “Responding to FDA Form 483 Observations at
The USFDA has issued a Warning Letter to the Indian drug manufacturing facility of Patcos
Janssen Vaccines Corp., a Johnson & Johnson company operating in Korea, was issued an FDA
The USFDA issued a Warning letter to Hikal’s API facility in Jigani, Bangalore, India. The
The USFDA issued a Warning letter to Amneal Pharmaceuticals following critical deviations observed during an
In a blog posted on 8 August 2025, MHRA’s Chris Jones (IAG Chair) and Himal Makwana
USFDA issued a Warning letter to Glenmark Facility at Pithampur (FEI 3008565058) in July 2025.
USFDA has issued a Warning letter to Glenmark Pharma’s Pithampur manufacturing facility (FEI 3008565058). The
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter in June 2025
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
