# SynCardia Systems LLC – FDA Inspection, Aug 18, 2017

Source: https://www.keypedia.com/records/fda_inspections/syncardia-systems-llc/8b20043a-478e-4325-8515-86ae3fa807c1
Source feed: FDA_Inspections

> FDA inspection 1022176 of SynCardia Systems LLC, August 18, 2017. Classification: Official Action Indicated (OAI). 2 citations under 21 CFR parts 803 and 820. Form 483 issued. 6 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1022176
- Company Name: SynCardia Systems LLC
- Inspection Date: 2017-08-18
- Classification: Official Action Indicated (OAI)
- Classification Code: OAI
- Project Area: Postmarket Assurance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 2

## Related Documents

- FDA Inspection 1079700 - 2018-11-29
- FDA Inspection 1121472 - 2018-10-19
- FDA Inspection 1079737 - 2017-10-13
- FDA Inspection 922825 - 2015-04-17
- FDA Inspection 826059 - 2013-03-28

## Related Officers

- [Investigator](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/syncardia-systems-llc/077da59d-e624-48a3-ae9c-042b75ed84db

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