# FDA 483 - Aeton Medical - August 09, 2023

Source: https://www.keypedia.com/records/483/aeton-medical/2fbfc253-a8b1-426c-a613-3b38cf5afed6

> FDA 483 for Aeton Medical on August 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aeton Medical
- Inspection Date: 2023-08-09
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Aeton Medical in Pennsauken, NJ, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate device history records, an incomplete device master record, and poorly established corrective and preventive action procedures. These issues indicate a lack of control over manufacturing processes and quality management for their healing caps.

## Related Documents

- [483 - 2023-08-09](https://www.keypedia.com/records/483/aeton-medical/20c50cc4-2c25-4b02-9f35-279662679348)

## Related Officers

- [Frank J. Marciniak](https://www.keypedia.com/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)

Company: https://www.keypedia.com/companies/aeton-medical/4adb1881-1c5b-48d0-82ae-70c192709335

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248