ZYDUS LIFESCIENCES LIMITED – FDA 483, Oct 13, 2026

Zydus Lifesciences Limited, a non-sterile drug manufacturer in Sanand, India, received an FDA Form 483 citing multiple significant deficiencies. Observations included under-reported microbial growth in laboratory records and inadequate investigations for product discrepancies and out-of-trend results. The firm also lacked systems for DSCSA compliance, failed to perform performance verification on FTIR instruments, and continued reduced testing of materials despite specification failures.