Author: Qvents Team

NDSRI Nitrosocinacalcet: Aurobindo Recal

Aurobindo is recalling Cinacalcet tablets in US due to nitrosamine NDSRI impurity N-Nitroso-cinacalcet. Aurobindo has

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

API Key SM Source Concerns: Lupin Recall

Authored by: Venkiteswaran.T.K, Subrangshu Chourdhary, Satish Reddy Lupin is recalling over 600,000 bottles of Ramipril capsules across different

Investigation Docs Outside EDMS, Hold Ti

Authored by: Venkiteswaran.T.K, Subrangshu Chourdhary, Srinivas Churya Jubilant Generics Roorkee facility was inspected in January

Data Integrity, Cleaning Issues: Granule

USFDA inspected Granules India’s  Finished Dosage and PFI facility (FEI 3004097901) at Gagillapur Village, Hyderabad

Nitrosocinacalcet Nitrosamine Impurity T

In October 2024, Accord Healthcare recalled over 25 lots of Cinacalcet tablets in various strengths

Global Calcium USFDA 483: Critical Data

With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary The USFDA inspection

USFDA 483 to Torrent: Concerns on Handli

With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary, Veena Raj The USFDA Form

Warning letter Sun Pharma Dadra Unit: In

Sun Pharma’s Dadra Unit was issued FDA Warning letter in June 2024, following critical observations

Inadequacy of Investigations, Root cause

Laurus Synthesis was issued an Untitled Letter by USFDA in May 2024, following critical observations