Author: Qvents Team

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

Sun Pharma Dadra USFDA 483 cites Lack of

Sun Pharma Dadra unit (FEI 3004561553) was inspected by USFDA in December 2023 by FDA

Cipla Patalganga USFDA 483 highlights Cl

USFDA inspection of Cipla, Patalganga site manufacturing APIs and Tablets resulted in USFDA 483 with

Lupin USFDA 483 cites deficient failure

USFDA 483 to Lupin Pithampur in Mar 2023 (Inspectors Eileen A Liu, Yvins Dezan) cites