# FDA 483 - B-ONE ORTHO, CORP. - May 18, 2022

Source: https://www.globalkeysolutions.net/records/483/b-one-ortho-corp/a71002b8-41e5-4ad7-b8d2-20b1e13a5dfe

> FDA 483 for B-ONE ORTHO, CORP. on May 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B-ONE ORTHO, CORP.
- Inspection Date: 2022-05-18
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of B-ONE ORTHO, CORP. in Cedar Knolls, NJ, revealed inadequate procedures for corrective and preventive action. The firm failed to initiate corrective actions for nonconforming events related to its Mobio® Knee Implant system, where components were manufactured or certified to incorrect revision levels. This indicates a significant lapse in their quality system regarding product conformity.

## Related Officers

- [William R. Chang](https://www.globalkeysolutions.net/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)

Company: https://www.globalkeysolutions.net/companies/b-one-ortho-corp/b49ff65e-9cfa-4c03-9f84-cacd78b0b03f

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248