FDA 483 - Portable Therapeutix - November 12, 2024

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.