Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Aarti Drugs USFDA 483 Flags Unique Chall

Authored by: Venkiteswaran.T.K, SubrangshuChourdhary, Srinivas Churya, Satish Reddy, Sanjeev Kumar Singh Aarti Drugs API facility in Tarapur, India

Strengthen Analyst Qualification, Reduce

Authored by: Srinivas Churya In the pharmaceutical industry, analytical division and analytical laboratories plays a

Zydus Vadodara USFDA 483 cites Contamina

USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations.

USFDA 483 to Eugia Polepally unit cites

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

Instrument Settings, Operator Training:

Following the USFDA inspection  during 8-16 April 2019 at Torrent, Indrad, India (FEI 3005029956) by

Lack of Training and Awareness Across Ma

USFDA 483 to Lupin Pithampur unit cite Inadequacy of training and awareness across the management