# FDA 483 - Miach Orthopaedics - April 23, 2025

Source: https://www.globalkeysolutions.net/records/483/miach-orthopaedics/c659bdc9-e565-45ce-8e8a-41d4d8def452

> FDA 483 for Miach Orthopaedics on April 23, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Miach Orthopaedics
- Inspection Date: 2025-04-23
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Miach Orthopaedics in Westborough, MA, a manufacturer of the BEAR Implant medical device, revealed significant deficiencies across its quality system. Observations included inadequate procedures for process control, design verification and validation related to implant hydration, and a failure to adequately manage complaints and corrective actions. These issues raise concerns about the device's quality, safety, and consistent performance in the field.

## Related Officers

- [Sara M. Onyango](https://www.globalkeysolutions.net/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.globalkeysolutions.net/companies/miach-orthopaedics/20fc54c8-7f5e-431b-9d45-39f6554a9d55

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