FDA Inspection
Dynavision Global Holdings LLCDynavision Global Holdings LLC – FDA Inspection, Aug 31, 2023
Record Details
This FDA Inspection record concerns Dynavision Global Holdings LLC, with an inspection on August 31, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Teresa K. Kastner
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ID · deda4609-bb92-439c-badc-fe3f6f9283d4
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1216483
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Dynavision Global Holdings LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 29, 2019 | VAI | 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 1109742 - 2019-10-16
- FDA Inspection 1087784 - 2019-04-29
- FDA Inspection 1009933 - 2017-04-26
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