FDA 483 - PINNACLE LIFE SCIENCE PRIVATE LIMITED - April 22, 2024

Pinnacle Life Science Private Limited, a drug manufacturer in Solan, India, was inspected and cited for significant deficiencies across its quality, facilities, equipment, and laboratory control systems. The inspection revealed widespread data integrity issues, inadequate equipment qualification and maintenance, and failures in following established procedures and training requirements. These observations indicate a systemic lack of control over critical manufacturing and testing processes, posing a high risk to product quality and patient safety.