# FDA 483 - Newton Implant Systems, Inc. - July 19, 2022

Source: https://www.globalkeysolutions.net/records/483/newton-implant-systems-inc/626c62cb-8a5b-4375-b4e3-b0f6dc1c89e8

> FDA 483 for Newton Implant Systems, Inc. on July 19, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Newton Implant Systems, Inc.
- Inspection Date: 2022-07-19
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Newton Implant Systems, Inc. in San Diego, CA, revealed a significant deficiency regarding the lack of established written procedures for handling human bone products. The firm failed to implement appropriate procedures for the receipt, storage, shipment, and distribution of HCT/Ps, specifically bone graft products. These products were subsequently distributed to customers without the necessary procedural controls.

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## Related Officers

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Company: https://www.globalkeysolutions.net/companies/newton-implant-systems-inc/1f0919c6-0711-4f63-bc4d-d6bbb7afc011

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6