FDA Inspection
Vivalnk, Inc.FDA Inspection 1158487 - Vivalnk, Inc. - December 10, 2021
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Record Details
This FDA Inspection record concerns Vivalnk, Inc., with an inspection on December 10, 2021, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d9df94c9-988b-4959-9a56-11ddefb9bd5b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1158487
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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Other FDA inspections of Vivalnk, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |