Qvents

FDA Warning Letter to Viatris: Concerns

FDA has published the Warning Letter issued to the Viatris Pithampur facility in December 2024. This Warning

Growing Trend of Drug Recalls for NDSRIs

Adding to the number of recalls during 2024 for NDSRIs, Ascend (Alkem) is recalling the

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

Strengthen Analyst Qualification, Reduce

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

Deficiencies That Lead to Officiation Ac

Five different facilities of Eugia across India and US were inspected by USFDA between December

Global Calcium USFDA 483: Critical Data

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