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

Qvents Team
September 16, 2025

USFDA 483 to Eugia Polepally unit cites

USFDA had inspected Aurobindo’s Eugia SEZ Pvt Ltd facility at Polepally, Telengana in India in

Qvents
March 19, 2024

Concerns of Beta Lactam Contamination: U

Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER 07, 2022/ Observation 2 USFDA

Qvents
April 18, 2023