Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA issued a Warning letter to Glenmark Facility at Pithampur (FEI 3008565058) in July 2025.
Natco Pharma’s sterile products manufacturing facility at Rangareddy, Telengana (FEI 3004540906) was inspected by USFDA
Accord (Intas) initiated a recall of several lots of Levothyroxine tablets in the US for
Qvents Apps & ToolsNitrosamine and NDSRI Risk Assessment Tools – APIs, Drug Products, Excipients, Water
As per EUGMP requirements, EudraLex, Annex 16: Certification by a Qualified Person and Batch Release,
Author: Venkiteswaran.T.K The USFDA’s 2011 guidance on process validation advocates a life cycle approach and
In March 2025, Glenmark initiated recall of 23 products (148 lots) in US for cGMP
Qvents Apps & Tools Access the Excipient Risk Assessment Tool – Click Here According to
Authored by: Srinivas Churya This Quality Insight post presents a concise approach for selection and
Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with
