# FDA 483 - Insightra Medical Inc - January 27, 2025

Source: https://www.globalkeysolutions.net/records/483/insightra-medical-inc/964ef714-d1b6-464a-9d51-822380a4c3ca

> FDA 483 for Insightra Medical Inc on January 27, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Insightra Medical Inc
- Inspection Date: 2025-01-27
- Product Type: device
- Office Name: New Orleans District Office
- Summary: Insightra Medical Inc. in Clarksville, TN, was cited with three observations during an FDA inspection from January 21-27, 2025. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding inadequate documentation of corrective and preventive actions, poorly maintained customer complaint files, and failures to adequately establish and implement design change procedures. These issues, many of which are repeat observations from previous inspections, indicate a systemic lack of control over critical quality processes for medical devices.

## Related Documents

- [WARNING_LETTER - 2015-02-24](https://www.globalkeysolutions.net/records/warning_letter/insightra-medical-inc/37e19ffb-1161-49d8-844d-3fd92d40aebc)

## Related Officers

- [Jamie P. Webb](https://www.globalkeysolutions.net/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)

Company: https://www.globalkeysolutions.net/companies/insightra-medical-inc/06b59100-646c-4533-bf23-0a0f3944fb72

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea