# FDA 483 - Dynavision Global Holdings LLC - August 31, 2023

Source: https://www.globalkeysolutions.net/records/483/dynavision-global-holdings-llc/665330f8-9100-48fc-800f-96ba1c70804f

> FDA 483 for Dynavision Global Holdings LLC on August 31, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Dynavision Global Holdings LLC
- Inspection Date: 2023-08-31
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Dynavision Global Holdings LLC, a medical device manufacturer in Cincinnati, OH, was inspected by the FDA, revealing significant quality system deficiencies. The firm failed to adequately establish or implement procedures for corrective and preventive actions, complaint handling, nonconforming product control, and supplier management. Additionally, design verification results for the Dynavision D2 device were not properly documented in the design history file.

## Related Officers

- [Consumer Safety Officer, Medical Device Specialist](https://www.globalkeysolutions.net/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)

Company: https://www.globalkeysolutions.net/companies/dynavision-global-holdings-llc/c9a1a5b6-edec-4bae-8d9e-35669f15e99a

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22