FDA Inspection
Dynavision Global Holdings LLCDynavision Global Holdings LLC – FDA Inspection, Apr 29, 2019
Record Details
This FDA Inspection record concerns Dynavision Global Holdings LLC, with an inspection on April 29, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Teresa K. Kastner
View Company Profile
ID · 7367e977-15bf-4159-986e-96ee8a567fe4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087784
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 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 26, 2017 | OAI | 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 1009933 - 2017-04-26
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