FDA Inspection
Dynavision Global Holdings LLCDynavision Global Holdings LLC – FDA Inspection, Apr 26, 2017
Record Details
This FDA Inspection record concerns Dynavision Global Holdings LLC, with an inspection on April 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 968c0cfa-3ea4-4f1d-be61-f4f8795f7c39
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1009933
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dynavision Global Holdings LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 31, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 16, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 29, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Dynavision Global Holdings LLC
- FDA Inspection 1216483 - 2023-08-31
- FDA Inspection 1109742 - 2019-10-16
- FDA Inspection 1087784 - 2019-04-29
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