# FDA 483 - Newton Implant Systems, Inc. - August 18, 2025

Source: https://www.keypedia.com/records/483/newton-implant-systems-inc/8510645c-98e3-4fda-b6a8-8f12de04ffb0

> FDA 483 for Newton Implant Systems, Inc. on August 18, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Newton Implant Systems, Inc.
- Inspection Date: 2025-08-18
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Newton Implant Systems, Inc., an HCT/P storage and distributor in Vista, CA, revealed a failure to follow procedures for core Current Good Tissue Practice (CGTP) requirements. Specifically, the firm did not maintain complete and current records for warehouse maintenance and cleanliness verification as required by their own SOP. This lapse affects numerous units of tissue that have been shipped out and are currently in storage.

## Related Documents

- [483 - 2022-07-19](https://www.keypedia.com/records/483/newton-implant-systems-inc/626c62cb-8a5b-4375-b4e3-b0f6dc1c89e8)
- [483 - 2025-08-18](https://www.keypedia.com/records/483/newton-implant-systems-inc/74513da6-42ec-411b-8302-442a22434754)

## Related Officers

- [Eric Zhu](https://www.keypedia.com/people/eric-zhu/32919a8f-841a-441b-a489-8495f2e16993)

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

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