FDA Inspection
LivaNova USA, Inc.FDA Inspection 891132 - LivaNova USA, Inc. - August 22, 2014
Record Details
This FDA Inspection record concerns LivaNova USA, Inc., with an inspection on August 22, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- LivaNova USA, Inc.
- Inspection Date
- August 22, 2014
- Product Type
- Devices
View Company Profile
ID · 67df494a-d4aa-401e-9a34-5efce8b04950
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 891132
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 803.50(a)(2)Individual Report of Malfunction
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Other FDA inspections of LivaNova USA, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2026 | Not classified | Dallas District Office | |
| February 20, 2025 | Not classified | Dallas District Office | |
| August 12, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 4, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 7, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LivaNova USA, Inc.
- FDA Inspection 1302110 - 2026-01-16
- FDA Inspection 1261017 - 2025-02-20
- FDA Inspection 1180294 - 2022-08-12
- FDA Inspection 1141170 - 2021-05-04
- FDA Inspection 808850 - 2012-12-07
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