# FDA 483 - Portable Therapeutix - November 12, 2024

Source: https://www.keypedia.com/records/483/portable-therapeutix/dee5dce8-0cce-49e8-8d08-0ffc96248a83

> FDA 483 for Portable Therapeutix on November 12, 2024. Product: devices. 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: devices
- Office Name: Food and Drug Administration
- Summary: During an FDA inspection conducted from October 29 to November 12, 2024, Portable Therapeutix, a specification developer and repackager/relabeler in Houston, TX, received a Form FDA-483 citing significant observations regarding its quality system. The company was found to have inadequate procedures for design changes, specifically failing to adequately verify design modifications before implementation. Crucially, the firm's corrective and preventive action (CAPA) system was not effectively established or implemented, with instances of unverified CAPA effectiveness and uncompleted actions, a repeat observation from a prior 2018 inspection. Further observations included deficiencies in maintaining device history records (DHRs), which lacked essential manufacturing details and failed to incorporate nonconformances, contrary to 21 CFR Part 820 requirements. Procedures for finished device acceptance were also insufficient, lacking defined testing requirements and sampling techniques for device release, another repeat observation, particularly concerning given 429 complaints since 2018, many due to component issues. Lastly, document control procedures were found to be inadequate, as obsolete and current documents were not properly managed or identified, a third repeat observation. Portable Therapeutix must address these systemic quality control issues to ensure regulatory compliance and product quality.

## Related Documents

- [483 - 2024-11-12](https://www.keypedia.com/records/483/portable-therapeutix/2a2124d0-0e09-44b9-9cff-3dbe84152309)

## Related Officers

- [Kellie B. Kelm](https://www.keypedia.com/people/kellie-b-kelm/df5eaff8-c13d-49e8-b2f6-c3d42a9a7daf)
- [Shelby N. Turner](https://www.keypedia.com/people/shelby-n-turner/77268f33-ae48-4e30-abad-4d79c1077185)

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

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516