FDA 483 - INNOXEL LIFESCIENCES PRIVATE LIMITED - May 02, 2025

Hmoxel Lifesciences Private Limited in Kotambi, India, received a Form 483 for significant deficiencies in their written production and process control procedures. The inspection revealed issues with undocumented mixing step interruptions in batch records and a general Standard Operating Procedure (SOP) for audit trail review that lacked system-specific instructions. These findings indicate a lack of adequate control over manufacturing processes and data integrity.