# FDA 483 - TT Electronics - June 29, 2026

Source: https://www.keypedia.com/records/483/tt-electronics/9b826dfc-b7e3-48ba-97ab-ff3f2437807b

> FDA 483 for TT Electronics on June 29, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TT Electronics
- Inspection Date: 2026-06-29
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: TT Electronics, a contract medical device manufacturer in Perry, OH, was cited for significant deficiencies in its quality system. Observations included inadequate documentation of risk management processes, a failure to apply a risk-based approach to the quality management system using post-market data, and insufficient documentation for infrastructure maintenance activities. Additionally, the firm failed to adequately maintain records of corrective actions, including a deleted corrective action for an assembly issue.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.keypedia.com/companies/tt-electronics/01a7b392-a20f-48be-ba1a-f74e92d107c7

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