Discussion forum for Pharma Quality events, Regulatory Actions

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

IPCA unit at Dhar, Madhya Pradesh, India

Failure to thoroughly review unexplained discrepancies. Out of specification results on multiple batches of tablets

Qvents
July 13, 2023

USFDA 483 / IPCA / June 2023 /Failure of

USFDA Inspected IPCA (Ratlam, India) site in June 2023, Inspectors – Rajiv R Srivastava, Salim

Qvents
July 7, 2023

USFDA 483 / Sun Pharma, Mohali, India /

USFDA 483 to Sunpharma, Mohali unit in Aug 2022 cites deficiencies in Chromatographic integration and

Qvents
May 8, 2023