483
INNOXEL LIFESCIENCES PRIVATE LIMITEDINNOXEL LIFESCIENCES PRIVATE LIMITED – FDA 483, May 2, 2025
Record Details
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.
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ID · d8af89dd-5606-44b3-9510-b981106a9154
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