# FDA 483 - Proxtalker.Com, Llc - June 08, 2023

Source: https://www.globalkeysolutions.net/records/483/proxtalkercom-llc/7f1b291f-e816-4899-913b-f03d9833d935

> FDA 483 for Proxtalker.Com, Llc on June 08, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Proxtalker.Com, Llc
- Inspection Date: 2023-06-08
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Proxtalker.com, Llc in Waterbury, CT was inspected by the FDA from June 6-8, 2023. The inspection revealed a significant issue regarding the lack of documented acceptance activities and quality testing results within the device history records for their powered communication system medical devices. This indicates a serious deficiency in their quality system for medical device manufacturing.

## Related Officers

- [Power Trader/Data Scientist](https://www.globalkeysolutions.net/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.globalkeysolutions.net/companies/proxtalkercom-llc/e8399570-9bbe-475f-93cf-3d5c311abef0

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7