WIZCURE PHARMAA PRIVATE LIMITED – FDA 483, Dec 3, 2025

Wizcure Pharmaa Private Limited, a sterile drug manufacturer in Bhiwadi, India, received a Form 483 with severe observations. The inspection revealed significant data integrity issues, including falsified microbiology records and pre-filled test results, alongside widespread deficiencies in aseptic processing, environmental monitoring, and quality control practices. These findings indicate a critical lack of control over sterile drug manufacturing processes and data reliability.