FDA Inspection
SynCardia Systems LLCSynCardia Systems LLC – FDA Inspection, Aug 18, 2017
Record Details
This FDA Inspection record concerns SynCardia Systems LLC, with an inspection on August 18, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8b20043a-478e-4325-8515-86ae3fa807c1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1022176
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SynCardia Systems LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 29, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 19, 2018 | Not classified | Denver District Office | |
| October 13, 2017 | Not classified | Denver District Office | |
| April 17, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 28, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for SynCardia Systems LLC
- 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
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