# FDA 483 - TAMA Research Corporation - October 05, 2023

Source: https://www.globalkeysolutions.net/records/483/tama-research-corporation/004ef99f-bf41-4f56-be60-d14e3eedeb28

> FDA 483 for TAMA Research Corporation on October 05, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: TAMA Research Corporation
- Inspection Date: 2023-10-05
- Product Type: device
- Office Name: Denver District Office
- Summary: TAMA Research Corporation, a medical device manufacturer in Scottsdale, AZ, was inspected by the FDA from October 3-5, 2023. The inspection revealed two significant issues: a failure to provide required Unique Device Identification (UDI) information for their TAMA BlueOnyx Pro device to the Global UDI Database, and inadequate record-keeping for complaint investigations. These findings indicate deficiencies in device identification and quality system processes.

## Related Documents

- [483 - 2019-04-22](https://www.globalkeysolutions.net/records/483/tama-research-corporation/c174024e-1729-4640-975e-9afc95fb587d)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/charles-l-larson/4232255d-bfd6-4616-a854-c801e4c23e1c)

Company: https://www.globalkeysolutions.net/companies/tama-research-corporation/d8a63cbd-9d86-431c-9679-29746695e48d

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face