# FDA 483 - 410 Medical, Inc. - March 12, 2020

Source: https://www.globalkeysolutions.net/records/483/410-medical-inc/a5dabccd-3ab3-4e0a-873d-219b566df398

> FDA 483 for 410 Medical, Inc. on March 12, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: 410 Medical, Inc.
- Inspection Date: 2020-03-12
- Product Type: device
- Office Name: Atlanta District Office
- Summary: 410 Medical Inc. in Durham, NC, was inspected from March 9-12, 2020, and received a Form 483 with two observations. The inspection revealed deficiencies in the firm's medical device reporting (MDR) procedures, specifically regarding the identification and evaluation of potentially reportable events. Additionally, the firm failed to adequately maintain complaint files, with several found to be missing key information.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/david-e-lowe/1a2492c2-4a81-4486-b3af-37f6b7b5216a)

Company: https://www.globalkeysolutions.net/companies/410-medical-inc/20383801-3734-485f-9de7-f31ccbd51556

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7