# FDA 483 - AUSA MEDICAL DEVICES PVT LTD - March 05, 2026

Source: https://www.keypedia.com/records/483/ausa-medical-devices-pvt-ltd/89e93f69-7b42-4977-ba3e-affbe3c30b7f

> FDA 483 for AUSA MEDICAL DEVICES PVT LTD on March 05, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AUSA MEDICAL DEVICES PVT LTD
- Inspection Date: 2026-03-05
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of AUSA MEDICAL DEVICES PVT LTD in Bengaluru, India, a contract manufacturer, revealed significant deficiencies in its quality management system. The firm failed to adequately address recurring nonconformities, maintain effective risk management processes, and control essential quality records. These issues indicate a lack of robust controls over manufacturing processes and documentation.

## Related Officers

- [Esteban Beltran](https://www.keypedia.com/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.keypedia.com/companies/ausa-medical-devices-pvt-ltd/44852cbc-dc04-4558-ad39-f845d80b8b87

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