FDA 483 - Arene Life Sciences Private Limited - August 30, 2024

Arene Life Sciences Limited, an API manufacturer in Sangareddy, India, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in the proper performance and assessment of electronic equipment, specifically regarding power supply disruptions and their impact on data integrity. Additionally, the firm failed to contemporaneously record laboratory data, indicating issues with laboratory control mechanisms and documentation practices.