# FDA 483 - Insite One - October 31, 2025

Source: https://www.keypedia.com/records/483/insite-one/cd8887a6-0019-4328-8546-8305fc56716c

> FDA 483 for Insite One on October 31, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Insite One
- Inspection Date: 2025-10-31
- Product Type: device
- Office Name: New England District Office
- Summary: InsiteOne, LLC, a software manufacturer in Wallingford, CT, received a Form FDA 483 for inadequate complaint handling procedures. The firm failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, specifically by not determining if complaints were reportable as Medical Device Reports (MDRs). This indicates a deficiency in their quality system regarding post-market surveillance.

## Related Documents

- [483 - 2025-10-31](https://www.keypedia.com/records/483/insite-one/fe9e6b46-f020-4752-bdb5-ad6d55e2a745)

## Related Officers

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

Company: https://www.keypedia.com/companies/insite-one/ad2c2511-9c74-4722-8aa1-632a60145a6a

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144