FDA 483 - Chirp Innovation, LLC - November 21, 2025
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An FDA inspection of Chirp Innovation, LLC, an importer and distributor of the Halo TENS/EMS Muscle Stimulator Medical Device, revealed significant deficiencies. The firm failed to establish essential quality system procedures, including those for management controls, CAPA, design controls, and complaint handling. Additionally, the company lacked written Medical Device Reporting (MDR) procedures and employed personnel without adequate training and experience to maintain a compliant quality management system.
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