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

During an inspection from October 19 to November 18, 2021, at MIRA, Inc., a medical device manufacturer located at 414 Quaker Hwy, Uxbridge, MA, the FDA observed several violations.

**Observation 1:** MIRA, Inc. failed to validate processes for its Cryo consoles and accessory probes. Specifically, there was no justification or evidence of validation for the selection and use of (b)(4) material in cryo probe assemblies.

**Observation 2:** Process control procedures were inadequate. Expired (b)(4) and (b)(4) components, with "USE BY" dates of March 2011 and November 2016 respectively, were found in the Cryo build cell and used in the manufacture of Cryo 4000 ophthalmic surgical devices (consoles and probes). There was no written record of (b)(4) use in the assembly procedure. The firm had not contained nonconforming devices or performed a Health Hazard Evaluation for potential bond failure.

**Observation 3:** Equipment calibration procedures were not adequately established. Finished device testing for Cryo CR4000 ophthalmic surgical consoles (serial numbers W06236-5, W06236-6, W06236-7) used pressure gages (b)(4) that had not undergone required calibration services, despite these devices being distributed to