FDA 483 - Agupunt USA Corp - March 25, 2026

Agupunt USA Corp, an importer of dry needling devices in Miami, FL, was cited for significant deficiencies during an FDA inspection. The firm failed to adequately implement procedures for Medical Device Reporting (MDR) by not evaluating complaints for reportability and lacking a functional Electronic Submission Gateway account. Additionally, the inspection revealed a critical gap in supply chain controls, as the firm lacked established inspection and release requirements for imported products upon their arrival in the U.S. warehouse, potentially allowing non-conforming devices to reach patients.