# FDA 483 - Portable Therapeutix - November 12, 2024

Source: https://www.globalkeysolutions.net/records/483/portable-therapeutix/2a2124d0-0e09-44b9-9cff-3dbe84152309

> FDA 483 for Portable Therapeutix on November 12, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Portable Therapeutix
- Inspection Date: 2024-11-12
- Product Type: device
- Office Name: Dallas District Office
- Summary: Portable Therapeutix, a specification developer and repackager/relabeler in Houston, TX, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to establish and adequately implement procedures for design changes, corrective and preventive actions, finished device acceptance, and document control. Additionally, device history records did not comply with requirements, and several observations were repeats from a previous inspection, indicating persistent issues.

## Related Officers

- [Jocelyn C. Turner](https://www.globalkeysolutions.net/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.globalkeysolutions.net/companies/portable-therapeutix/2a977659-be1e-4568-8f41-f3d85afbdf4a

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9