# FDA 483 - Kat Implants, LLC - September 16, 2022

Source: https://www.globalkeysolutions.net/records/483/kat-implants-llc/ace07e65-2bde-4e8e-b364-60470aa4143d

> FDA 483 for Kat Implants, LLC on September 16, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kat Implants, LLC
- Inspection Date: 2022-09-16
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Kat Implants, LLC in Portsmouth, NH, a manufacturer of dental implants, revealed two significant observations. The firm failed to adequately maintain complaint files, including not following its own procedures and lacking proper documentation for investigations and potential FDA reporting. Additionally, device history records were found to be deficient, with missing finished device forms and a lack of implementation for Unique Device Identifier requirements.

## Related Officers

- [Katarzyna Plona](https://www.globalkeysolutions.net/people/katarzyna-plona/ea20d6c6-5d2d-41a0-a755-0647fb9f3250)

Company: https://www.globalkeysolutions.net/companies/kat-implants-llc/42d59754-3a6c-415a-86ad-098ace1198b4

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