FDA 483 - MIRA, Inc. - March 07, 2023

An FDA inspection of MIRA, Inc. in Uxbridge, MA, a manufacturer of Class II medical devices, revealed two significant observations. The firm failed to adequately establish process control procedures, leading to the use of expired materials in device assembly, which was a repeat observation. Additionally, procedures for ensuring purchased products and services conform to specified requirements were not adequately established, with critical suppliers not being evaluated as per the firm's own procedures.