FDA Inspection
AUSA MEDICAL DEVICES PVT LTDAUSA MEDICAL DEVICES PVT LTD – FDA Inspection, Mar 5, 2026
Record Details
This FDA Inspection record concerns AUSA MEDICAL DEVICES PVT LTD, with an inspection on March 5, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- AUSA MEDICAL DEVICES PVT LTD
- Inspection Date
- March 5, 2026
- Product Type
- Medical Devices & Rad Health
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ID · dd9938df-dfc6-4fe5-bb1d-a1cc64f3d0a3
Inspection Facts
- Inspection number
- 1305572
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
3- ISO 13485:2016 Clause 4.2.4Lack of document control
- ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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Other FDA inspections of AUSA MEDICAL DEVICES PVT LTD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 22, 2023 | Not classified | Office of Inspections and Investigations |
Other documents for AUSA MEDICAL DEVICES PVT LTD
- FDA Inspection 1210307 - 2023-06-22
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