# Sivantos PTE LTD – FDA Inspection, Mar 30, 2023

Source: https://www.keypedia.com/records/fda_inspections/sivantos-pte-ltd/29ddfb61-6b65-4de6-ae23-f01d415ee337
Source feed: FDA_Inspections

> FDA inspection 1202193 of Sivantos PTE LTD, March 30, 2023. Classification: Voluntary Action Indicated (VAI). 2 citations under 21 CFR part 820. Form 483 issued. 1 other FDA inspection on record for this company.

---

## Details

- Record Type: FDA Inspection
- Inspection ID: 1202193
- Company Name: Sivantos PTE LTD
- Inspection Date: 2023-03-30
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Compliance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 2

## Related Documents

- [FDA Inspection 1062325 - 2018-07-26](https://www.keypedia.com/records/fda_inspections/sivantos-pte-ltd/65e3756f-f74e-4648-bc06-acfb70fb9618)

## Related Officers

- [Investigator](https://www.keypedia.com/people/catherine-j-laufmann/920b7656-2847-408d-ba15-3989283d8c94)

Company: https://www.keypedia.com/companies/sivantos-pte-ltd/007f14ae-7a87-48fe-95ff-cac5ff89930c

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7