FDA Inspection
Sivantos PTE LTDSivantos PTE LTD – FDA Inspection, Jul 26, 2018
Record Details
This FDA Inspection record concerns Sivantos PTE LTD, with an inspection on July 26, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 65e3756f-f74e-4648-bc06-acfb70fb9618
Inspection Facts
- Inspection number
- 1062325
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Sivantos PTE LTD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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