# FDA 483 - Synovo Production, Inc. - October 02, 2023

Source: https://www.keypedia.com/records/483/synovo-production-inc/4ba867a0-325a-47bc-a639-a2532c84c8ad

> FDA 483 for Synovo Production, Inc. on October 02, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synovo Production, Inc.
- Inspection Date: 2023-10-02
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Synovo Production, Inc. in Fullerton, CA, was inspected regarding its manufacturing of medical devices, specifically hip replacement systems. The inspection revealed significant deficiencies in quality system documentation, including failures in process validation, design history file establishment, corrective and preventive actions, supplier qualification, and personnel training. Many of these observations were repeats from a previous inspection, indicating a persistent lack of compliance.

## Related Documents

- [483 - 2022-10-26](https://www.keypedia.com/records/483/synovo-production-inc/0e1325ea-2bf6-47f0-87e8-a83309c57359)

## Related Officers

- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/synovo-production-inc/11640fba-a47f-4d38-98b8-c4fef1debc61

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