FDA 483 - MIRA, Inc. - June 12, 2024

MIRA, Inc. in Uxbridge, MA, was cited with three observations during an FDA inspection, indicating deficiencies in its quality system. The firm failed to adequately establish procedures for equipment calibration, resulting in the use of an out-of-calibration test gauge for medical device manufacturing. Additionally, MIRA, Inc. did not conduct internal quality audits or management reviews in 2023, contrary to its own established procedures.