# FDA 483 - Electro Cap International Inc - March 01, 2024

Source: https://www.keypedia.com/records/483/electro-cap-international-inc/0147463d-e8c1-4916-9776-8b40bd0fc71f

> FDA 483 for Electro Cap International Inc on March 01, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Electro Cap International Inc
- Inspection Date: 2024-03-01
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Electro Cap International Inc. in Eaton, OH, was inspected by the FDA from February 27 to March 1, 2024. The inspection revealed that the firm failed to document and adequately maintain acceptance activities, specifically quality verification tests, for their Electrode, Cutaneous Electro-Cap device. This indicates a significant lapse in their device history record keeping and final inspection procedures.

## Related Officers

- [Amber M. Capello-Jones](https://www.keypedia.com/people/amber-m-capello-jones/d34f92a0-d580-4028-9d31-c6cd7c13ce0f)

Company: https://www.keypedia.com/companies/electro-cap-international-inc/d81d4652-d958-4548-930e-dcae58de11f0

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22