# FDA 483 - Jazz Imaging - October 24, 2022

Source: https://www.globalkeysolutions.net/records/483/jazz-imaging/d0c9a8ad-1446-4e7e-8af5-c93e013696cb

> FDA 483 for Jazz Imaging on October 24, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Jazz Imaging
- Inspection Date: 2022-10-24
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Jazz Imaging in San Jose, CA, from October 12-24, 2022, revealed significant deficiencies in its quality system as a medical device manufacturer. The firm failed to adequately document management reviews, training, supplier evaluations, process validations, equipment calibrations, quality audits, complaint investigations, and corrective and preventive actions. Additionally, the company did not perform required IQ/OQ/PQ for manufacturing equipment.

## Related Officers

- [Jeffrey S Buckser](https://www.globalkeysolutions.net/people/jeffrey-s-buckser/deea4f9e-858f-4325-828e-56044c40a570)

Company: https://www.globalkeysolutions.net/companies/jazz-imaging/b5e408c8-182b-44b0-9ba8-89d897fc4932

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b