FDA 483 - Calmare Therapeutics, Inc. - May 22, 2024

An FDA inspection of Calmare Therapeutics, Inc. in Shelton, CT, a specification developer for a Class II Scrambler Therapy MC-5A TENS device, revealed significant deficiencies in their quality system. The firm was cited for not establishing fundamental procedures for design control, quality audits, management review, MDRs, complaint handling, and corrective and preventive actions. Several of these observations were repeats from a previous inspection in 2017, indicating a persistent lack of compliance with essential regulatory requirements.