FDA 483 - MIRA, Inc. - November 18, 2021

MIRA, Inc. in Uxbridge, MA, was inspected regarding its manufacturing of Cryo ophthalmic surgical devices. The inspection revealed significant deficiencies in process validation, process control, equipment calibration, and document control. These issues indicate a lack of adherence to quality system requirements, potentially impacting the safety and efficacy of distributed medical devices.