FDA Inspection
LivaNova USA, Inc.FDA Inspection 808850 - LivaNova USA, Inc. - December 07, 2012
Record Details
This FDA Inspection record concerns LivaNova USA, Inc., with an inspection on December 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- LivaNova USA, Inc.
- Inspection Date
- December 7, 2012
- Product Type
- Devices
View Company Profile
ID · e840ba12-b209-4489-80b4-8681db659f37
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 808850
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(h)Incorrect translation to production specifications
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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 |
| August 22, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 891132 - 2014-08-22
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