# FDA 483 - Pontis Orthopaedics, LLC - July 05, 2018

Source: https://www.globalkeysolutions.net/records/483/pontis-orthopaedics-llc/2492956b-ccec-4c04-b6e9-1809d1b06c49

> FDA 483 for Pontis Orthopaedics, LLC on July 05, 2018. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pontis Orthopaedics, LLC
- Inspection Date: 2018-07-05
- Product Type: devices
- Office Name: San Francisco District Office
- Summary: During an FDA inspection conducted from June 28 to July 5, 2018, medical device manufacturer Pontis Orthopaedics, LLC received a Form FDA 483 detailing significant issues. The inspection identified eight observations indicating non-compliance with quality system regulations. Key violations include a repeat observation concerning the inadequate validation of the sterilization process for the PONTiS Flexor Tendon Repair System, where new components were adopted without sufficient evaluation. Additionally, the company failed to adequately document and verify the effectiveness of corrective and preventive actions, with many closed records lacking verification and some remaining open. Risk analysis for their tendon repair system was found insufficient, as significant residual risks were not adequately mitigated or clinically evaluated per internal procedures. Further issues involved the improper control of nonconforming incoming products, with required reports not generated. A repeat observation highlighted inadequate procedures for evaluating and approving quality system consultants. The firm also failed to conduct internal quality audits and management reviews at specified intervals in 2016 and 2017, hindering the assessment of the quality system's effectiveness. Finally, several critical quality system records, including nonconformance, complaint, and supplier records, were missing or incomplete. Pontis Orthopaedics is required to promptly address these observations by implementing corrective actions to ensure compliance with medical device quality system requirements.

## Related Documents

- [483 - 2018-07-05](https://www.globalkeysolutions.net/records/483/pontis-orthopaedics-llc/4c665373-e00c-4c05-b284-fb508e5527df)

## Related Officers

- [Chief Operating Officer](https://www.globalkeysolutions.net/people/thomas-w-ross/b1f4dae4-971c-4111-8bdc-1492c7b7796f)
- [Jude C. Dike](https://www.globalkeysolutions.net/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.globalkeysolutions.net/companies/pontis-orthopaedics-llc/5991f036-2715-4626-a7da-503817f9a8af

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df