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

Source: https://www.keypedia.com/records/483/innoxel-lifesciences-private-limited/d8af89dd-5606-44b3-9510-b981106a9154

> FDA 483 for INNOXEL LIFESCIENCES PRIVATE LIMITED on May 02, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: INNOXEL LIFESCIENCES PRIVATE LIMITED
- Inspection Date: 2025-05-02
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

Company: https://www.keypedia.com/companies/innoxel-lifesciences-private-limited/0dc5686b-60b1-4548-b527-0e81ccf7e674

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8