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

Source: https://www.keypedia.com/records/483/mira-inc/1e199d6e-dcaf-49b8-8868-86dc4939163a

> FDA 483 for MIRA, Inc. on June 12, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MIRA, Inc.
- Inspection Date: 2024-06-12
- Product Type: device
- Office Name: New England District Office
- Summary: 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.

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## Related Officers

- [Katarzyna Plona](https://www.keypedia.com/people/katarzyna-plona/ea20d6c6-5d2d-41a0-a755-0647fb9f3250)

Company: https://www.keypedia.com/companies/mira-inc/059e0ec6-1d4e-4954-9c54-b6aa3232d2c2

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144