FDA Inspection
Vivalnk, Inc.Vivalnk, Inc. – FDA Inspection, May 12, 2026
Record Details
This FDA Inspection record concerns Vivalnk, Inc., with an inspection on May 12, 2026, issued by the San Francisco District Office, covering medical devices & rad health.
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ID · f47b338b-da53-419f-9d35-e4b27edb6957
Inspection Facts
- Inspection number
- 1318856
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 8.2.2Lack of documented justification for not investigating complaint(s)
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Vivalnk, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 10, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 8, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vivalnk, Inc.
- FDA Inspection 1158487 - 2021-12-10
- FDA Inspection 1041029 - 2018-01-08
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